ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000065392

Ethics application status

Approved

Date submitted

15/12/2016

Date registered

12/01/2017

Date last updated

24/04/2024

Date data sharing statement initially provided

5/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

OPTimising IMmunisation Using Mixed schedules (OPTIMUM): comparing allergic outcomes in infants following pertussis vaccination

Scientific title

A double-blind, randomised, controlled trial to compare allergic outcomes in children following vaccination with acellular pertussis antigen given at 2 months of age versus whole cell pertussis in the infant vaccine schedule

Secondary ID [1]

CVID/2013-04

Universal Trial Number (UTN)

U1111-1190-6907

Trial acronym

OPTIMUM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergy

Pertussis vaccination

Condition category

Condition code

Inflammatory and Immune System

Allergies

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

0.5ml,Pentabio vaccine (Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B- haemophilus influenzae type b) administered by intramuscular injection at approximately 6 to <12 weeks of age, together with the standard schedule of vaccines in accordance with the current Australian National Immunisation Program Schedule (group 1)

0.5ml of Infanrix Hexa (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio, and Haemophilus influenzae type b (DTaP-HB-IPV-Hib) administered by intramuscular injection at approximately 4 and 6 months of age.

0.5ml of Infanrix-IPV (Combined Diphtheria-Tetanus-acellular Pertussis (DTPa) and Inactivated Poliovirus) administered by intramuscular injection at approximately 18 months of age.

Each participant in the intervention group will receive the above 4 vaccines.

Intervention code [1]

Prevention

Comparator / control treatment

0.5ml Infanrix Hexa vaccine (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio, and Haemophilus influenzae type b (DTaP-HB-IPV-Hib) administered by intramuscular injection at approximately 6 to <12 weeks, together with the standard schedule of vaccines in accordance with the current Australian National Immunisation Program Schedule (group 2)

0.5ml of Infanrix Hexa (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio, and Haemophilus influenzae type b (DTaP-HB-IPV-Hib) administered by intramuscular injection at approximately 4 and 6 months of age.

0.5ml of Infanrix-IPV (Combined Diphtheria-Tetanus-acellular Pertussis (DTPa) and Inactivated Poliovirus) administered by intramuscular injection at approximately 18 months of age.

Each participant in the comparator group will receive the above 4 vaccines.

Control group

Active

Outcomes

Primary outcome [1]

The number and proportion of participants in each group with IgE mediated food allergy: IgE mediated food allergy with evidence of food sensitisation on skin prick test (SPT) by 12 months old and confirmed (where necessary) by medically supervised oral food challenge(s) (OFC). For the purpose of this trial, if either of the following conditions are met, the study participant will be considered to have reached the primary endpoint:
1) Unequivocal evidence of IgE mediated food allergy, defined as:
(i) A positive OFC with evidence of sensitisation on SPT to the food of interest OR
(ii) History of clinician-confirmed food anaphylaxis, with symptoms affecting at least two of the following: skin, gastrointestinal tract, respiratory tract, cardiovascular system; AND evidence of sensitisation on SPT to the food of interest.
2) Highly probable IgE-mediated food allergy
(i) A history of food allergic reaction (consistent with PRACTALL criteria), with evidence of sensitisation on SPT to the food of interest.

Timepoint [1]

12 months of age

Secondary outcome [1]

The number and proportion of participants in each study group by approximately 12 months old who have:

1) a SPT 1mm greater than the negative control

2) a SPT greater than or equal to 3mm greater than the negative control

to at least one allergen.

Timepoint [1]

12 months of age

Secondary outcome [2]

IgE titre to tetanus toxoid vaccine antigen following vaccination.
For each child in each study group we will measure the anti-tetanus IgE titre (number and proportion above assay limit of detection) and fold-rise in the log of the titre. Plasma tetanus specific IgE will be measured using the ImmunoCAP Tetanus Specific IgE assay

This endpoint applied to stage 1 participants only.

Timepoint [2]

1) Immediately prior to a third pertussis-containing vaccine dose at approximately 6 months of age, and
2) 21-35 days post vaccination at approximately 6 months of age

Secondary outcome [3]

IgE titre to egg white antigen following vaccination.
For each child in each study group we will measure the anti- egg white antigen IgE titre (number and proportion above assay limit of detection) and fold-rise in the log of the titre. Plasma egg white specific IgE will be measured using the ImmunoCAP egg white specific IgE assay.

This endpoint applied to stage 1 participants only.

Timepoint [3]

1) Immediately prior to a third pertussis-containing vaccine dose at approximately 6 months of age, and
2) 21-35 days post vaccination at approximately 6 months of age

Secondary outcome [4]

IgE titre to whole egg antigen following vaccination.
For each child in each study group we will measure the anti- whole egg antigen IgE titre (number and proportion above assay limit of detection) and fold-rise in the log of the titre. Plasma whole egg specific IgE will be measured using the ImmunoCAP whole egg specific IgE assay

This endpoint applied to stage 1 participants only.

Timepoint [4]

1) Immediately prior to a third pertussis-containing vaccine dose at approximately 6 months of age, and
2) 21-35 days post vaccination at approximately 6 months of age

Secondary outcome [5]

Total IgE titre following vaccination.
For each child in each study group we will measure the total IgE titre (number and proportion above assay limit of detection) and fold-rise in the log of the titre. Total plasma IgE will be assessed using the ImmunoCAP Total IgE assay.

This endpoint applied to stage 1 participants only.

Timepoint [5]

1) Immediately prior to a third pertussis-containing vaccine dose at approximately 6 months of age, and
2) 21-35 days post vaccination at approximately 6 months of age

Secondary outcome [6]

Stage 1: Local adverse events (injection site reaction e.g. pain, redness) as captured in the participant study diary: The proportion of infants with each type of local adverse events (AE), and the proportion with at least one local AE, in each study group up to 7 days after: 1) The first vaccination at approximately 2 months of age. 2) The second vaccination at approximately 4 months of age. 3) The third vaccination at approximately 6 months of age. 4) The first booster vaccination at approximately 18 months old . Stage 2: First 150 enrolments at PCH/Telethon Kids Institute only. Local adverse events (injection site reaction e.g. pain, redness) as captured in the participant study diary: The proportion of infants with each type of local AE, and the proportion with at least one local AE, in each study group up to 7 days after: 1) The first vaccination at approximately 2 months of age. 2) The first booster vaccination at approximately 18 months old.

Timepoint [6]

1) The first vaccination at approximately 2 months of age (stage 1 and 2 (first 150 enrolments at PCH/Telethon Kids Institute only). 2) The second vaccination at approximately 4 months of age (stage 1). 3) The third vaccination at approximately 6 months of age (stage 1). 4) The first booster vaccination at approximately 18 months old -stage 1 and 2 (first 150 enrolments at PCH/Telethon Kids Institute only).

Secondary outcome [7]

Systemic adverse events (systemic AEs): Stage 1: The proportion of infants with each type of systemic AE, and the proportion with at least one systemic AE, in each study group up to 7 days after: 1) The first vaccination at approximately 2 months of age. 2) The second vaccination at approximately 4 months of age. 3) The third vaccination at approximately 6 months of age. 4) The first booster vaccination at approximately 18 months old. Stage 2: First 150 enrolments at PCH/Telethon Kids Institute only. The proportion of infants with each type of systemic AE, and the proportion with at least one systemic AE, in each study group up to 7 days after: 1) The first vaccination at approximately 2 months of age. 2) The first booster vaccination at approximately 18 months old. Solicited systemic AEs that will be collected during this study include: fever greater than or equal to 38oC (axillary), drowsiness, irritability, anorexia (poor appetite), vomiting, diarrhoea and restlessness. These will be solicited on diary cards distributed to parents of infants in the study.

Timepoint [7]

1) The first vaccination at approximately 2 months of age -stage 1 and 2 (first 150 enrolments at PCH/Telethon Kids Institute only). 2) The second vaccination at approximately 4 months of age (stage 1). 3) The third vaccination at approximately 6 months of age (stage 1). 4) The first booster vaccination at approximately 18 months old -stage 1 and 2 (first 150 enrolments at PCH/Telethon Kids Institute only).

Secondary outcome [8]

The proportion of infants whose primary caregiver reports the vaccination experience as either unsatisfactory or very unsatisfactory (on a 5-point Likert scale from very satisfactory to very unsatisfactory) in each study group in stage 1 and the first 150 enrolments at PCH/Telethon kids Institute for stage 2 only.

Timepoint [8]

1) The first vaccination at approximately 2 months of age. (stage 1 & first 150 enrolments at PCH/Telethon kids Institute). 2) The second vaccination at approximately 4 months of age. (stage 1) . 3) The third vaccination at approximately 6 months of age. (stage 1). 4) The first booster vaccination at approximately 18 months old. (stage 1 and first 150 enrolments at PCH/Telethon kids Institute).

Secondary outcome [9]

The number and proportion of participants in each group with: a history of parent-reported clinician-diagnosed new onset eczema by 6 months AND a positive SPT to any allergen by approximately 12 months old.

Timepoint [9]

6 months and 12 months

Secondary outcome [10]

The number and proportion of participants in each group with: a history of parent-reported clinician-diagnosed new onset eczema by 12 months AND a positive SPT to any allergen by approximately 12 months old.

Timepoint [10]

12 months

Secondary outcome [11]

Proportion of children with a greater than or equal to 4-fold rise in pertussis toxin (PT) specific IgG at 7, 18 and 19 months of age. This endpoint applies to stage 1 and the first 300 enrollments at Telethon kids Institute for stage 2 only. IgG serum antibodies directed against pertussis toxin (PT) will be assessed using a microsphere-based multiplex assay

Timepoint [11]

7, 18 and 19 months

Secondary outcome [12]

Proportion of children with pneumococcal vaccine serotype-specific IgG greater than or equal to 0.35 µg/mL at 7 and 18 months of age. This applies to stage 1 and the first 300 enrolments at Telethon Kids Institute for stage 2 only. IgG serum antibodies directed against pneumococcal will be assessed using a microsphere-based multiplex assay.

Timepoint [12]

7 months, 18 months

Secondary outcome [13]

Proportion of children with polyribosylribitol phosphate (PRP, capsular polysaccharide of Hib)-specific IgG greater than or equal to 1.0 µg/mL at 7 and 18 and 19 months of age. IgG serum antibodies directed against (PRP, capsular polysaccharide of Hib) will be assessed using a microsphere-based multiplex assay.

Timepoint [13]

7 months, 18 months

Secondary outcome [14]

Proportion of children with a greater than or equal to 4-fold rise in filamentous haemagglutinin (FHA) specific IgG at 7, 18 and 19 months of age. IgG serum antibodies directed against FHA will be assessed using a microsphere-based multiplex assay.

Timepoint [14]

7, 18 and 19 months

Secondary outcome [15]

Proportion of children with a greater than or equal to 4-fold rise in pertactin (PRN) specific IgG at 7, 18 and 19 months of age. IgG serum antibodies directed against PRN will be assessed using a microsphere-based multiplex assay.

Timepoint [15]

7, 18 and 19 months

Secondary outcome [16]

Proportion of children with tetanus toxoid specific IgG a greater than or equal to 0.1 IU/mL at 7, 18 and 19 months of age. IgG serum antibodies directed against tetanus toxoid will be assessed using a microsphere-based multiplex assay.

Timepoint [16]

7, 18 and 19 months of age.

Eligibility

Key inclusion criteria

An eligible infant must fulfill all of the following:
* Healthy male or female infant aged 6 to 11 weeks and 6 days old
* Born on or after 32 weeks
* Parent or guardian understands the information provided and is willing and able to give informed consent for participation in the trial
* Infant known to be free of significant medical problems as determined by a medical history and clinical examination by a medically qualified investigator
* Parent has access to a telephone
*Parent or guardian who is able and willing to comply with the requirements of the protocol in the opinion of an investigator
*Willing to allow his or her general practitioner and/or paediatrician and/or immunisation provider and/or other parties involved in the treatment of their child , to be notified of participation in the trial
*Willing to allow the study team to obtain information from the infant’s doctor, other health care professionals, hospitals or laboratories concerning the infant’s health from enrolment until 1 month after the 18-month vaccinations.
* Be available for the entire study period

Minimum age

6 Weeks

Maximum age

11 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

The participant may not enter the trial if ANY of the following apply:
* History of pre-existing parent-reported clinician diagnosed IgE-mediated food allergy
* History of pertussis infection
* Receipt of any prior vaccine, except for a single birth dose of hepatitis B vaccine within the first 7 days of life.
* Contra-indication to any routine infant immunisation: History of allergy, including anaphylaxis, to any vaccine or vaccine component
* Contra-indication to paracetamol
* Receipt of investigational vaccines/drugs, other than the vaccines used in the study, since birth or their planned use during the study period, until the final study visit (i.e. at approximately 19 months of age).
* Receipt, or planned receipt, of any non-routine vaccines within 14 days after the first dose of pertussis containing vaccine
* Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone >0.5mg/kg/day)
* Serious chronic illness including severe congenital anomalies affecting heart, brain and/or lungs.
* History of any neurologic disorders or seizures
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
* Planned travel to any country that remains at risk of a poliomyelitis outbreak at any time before the final phone/electronic contact (i.e. at approximately 19 months of age.)
* Parents who plans to move out of the geographical area where the study would be conducted
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be randomised 1:1 to one of the two arms (wP vs aP) of the study.

On the day of first scheduled vaccination at age 6 to < 12 weeks (42 to 83 days), participants for whom all eligibility criteria have been satisfied and for whom informed consent for participation has been obtained from the legally responsible care-giver, will be randomised once. An unblinded pharmacist or research nurse will record the participant’s identifiers and a sequential study number; and then obtain the next contiguous allocation (i.e. the lowest available randomisation number) from a randomisation list which is concealed in and A4 non-transparent envelope from all other study staff. The randomisation number will be recorded in the case report form (CRF). At the point of randomisation, the participant will be considered enrolled into the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The computer-generated allocation sequence will be based on random permuted blocks with block sizes of 6,8 and 10 individuals.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety

Statistical methods / analysis

Participant demographics and baseline characteristics will be summarised and tabulated by vaccine arm (exclusive aP vs single priming dose of wP) using descriptive statistics. Continuous variables with symmetric distributions will be summarised using mean and standard deviation. Continuous variables with asymmetric distributions will be summarised using median and interquartile range. Categorical and binary variables will be summarised as frequency and percentage.

The primary endpoint is a single binary variable indicating positive for food-allergy at age 12 months or not. Analyses will be based on the ITT population.
The trial considers evidence of a positive treatment effect as a large one-sided posterior probability that the primary endpoint was reduced in the treatment arm compared to the control arm. The threshold for this posterior probability was determined following extensive trial simulations and is set to 0.95.
For the primary endpoint, the primary analysis will pool data across sites and use independent beta-binomial models to estimate the treatment effect as a difference in probability of food allergy between the study arms. Predictive probabilities are calculated using the posterior predictive distribution of this model.
Secondary analysis of the primary endpoint will use logistic regression models to estimate the treatment effect as a change in log-odds of food allergy between the study arms, adjusting for baseline prognostic covariates and investigating site as a random effect.
In both cases, results will be presented as posterior probabilities of the primary statistical hypothesis, and as summaries of the posterior distribution of the effect parameter in terms of means and highest density credible intervals.
The interim and final analyses for the primary endpoint, and secondary, and safety analyses, will be performed by the trial statistician.
The SAP will provide additional details on model specification which will be available on publication.
An analysis of data pertaining to the ‘atopic immunophenotype’ endpoints will be conducted by a trial statistician when the 150th participant has completed visit 5 (approximately 1 month after the 6-month vaccines). A pooled z test will be used to compare the proportion of children in each study group with a conversion in their total and antigen specific IgE, either from below to above the limit of detection, or a >3-fold increase in the log titre. If numbers permit, the Mann Whitney U test will be used to compare the fold rise in the log of the titres of tetanus toxoid, egg white and whole egg specific IgE.
Other secondary and safety endpoint will be analysed and compared cross treatment groups in accordance with their type. For binary endpoints, counts and proportions will be calculated for each treatment arm and compared across treatment groups. For continuous endpoints, means and standard deviations will be calculated and compared across treatment groups.
The SAP contains detailed hypotheses, methods, and thresholds that are referenced below but omitted for brevity and accessibility to a broad audience.
The first interim analysis will occur after the 200th subject has primary endpoint data available. Further interim analyses occur every 200 subjects with primary endpoint data up to when the maximum size has been enrolled, after which, interim stopping rules can no longer stop enrolment for futility or expected success.
The analysis performed at each interim will include:
• Modelling of the treatment effect,
• Prediction modelling to impute missing primary endpoint data for enrolled subjects yet to meet the primary endpoint, and for subjects yet to be enrolled up to the maximum sample size,
• Calculation of the predictive probability of success.
The possible decisions at each interim are to:
• Stop enrolment early for futility,
• Stop enrolment early for expected success,
• Continue enrolment to the next scheduled interim analysis.
The decision for futility is based on the predicted probability of success at the maximum sample size. If there is a very low probability of detecting a positive treatment effect, defined as a lower proportion of food-allergy in the treatment group compared to control, then enrolment will cease for futility. However, follow-up will continue for subjects already enrolled in the trial. At completion of follow-up we will undertake the final analysis.
The decision for expected success is based on the predicted probability of success at the sample size already enrolled. If there is a very high probability of detecting a positive treatment effect, defined as a lower proportion of food-allergy in the treatment group compared to control, then enrolment will cease for expected success. Follow-up will continue for subjects already enrolled in the trial. At completion of follow-up we will undertake the final analysis.
A decision to stop for futility is made if the predictive probability of success at the maximum sample size is less than 5% at the time of the interim analysis. A decision to stop for expected success is made if the predictive probability of success at the currently enrolled sample size is greater than 95% at the time of the interim analysis.
Note that the specified stopping rules can be overruled at the discretion of the CI, Sponsor or DSMC with reasonable justification, however, this has implications for the operating characteristics of the trial.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

9/03/2018

Actual

7/03/2018

Date of last participant enrolment

Anticipated

1/06/2024

Actual

Date of last data collection

Anticipated

1/10/2024

Actual

Sample size

Target

3000

Accrual to date

972

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment hospital [2]

Perth Children's Hospital - Nedlands

Recruitment hospital [3]

The Royal Childrens Hospital - Parkville

Recruitment hospital [4]

Sydney Children's Hospital - Randwick

Recruitment hospital [5]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6009 - Nedlands

Recruitment postcode(s) [3]

3052 - Parkville

Recruitment postcode(s) [4]

2031 - Randwick

Recruitment postcode(s) [5]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Telethon New Children’s Hospital Research Grant

Address [1]

Department of Health
189 Royal St Perth WA 6000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council (NHMRC)

Address [2]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

THE UNIVERSITY OF SYDNEY
Level 3, F23 Administration Building, Corner of Eastern Avenue and City Road
The University of Sydney NSW 2008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children and Adolescent Health Service Human Research Ethics Committee (EC00268)

Ethics committee address [1]

Hospital Avenue, Nedlands, Western Australia, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2017

Approval date [1]

13/04/2017

Ethics approval number [1]

RGS00019

Summary

Brief summary

The rise in atopy, particularly food allergy, over recent decades in Australia has coincided with a change from the routine use of Whole cell pertussis vaccination (DTwP) to Acellular pertussis vaccination (DTaP). These events may be causally related via the differential modulation of the Th1 and Th2 arms of the immune system by the different vaccines. A single first dose of DTwP followed by two doses of DTaP in the infant vaccination schedule may allow a more balanced immune response, and protection from subsequent atopy. Although a full DTwP vaccine course is more reactogenic than a full DTaP vaccine course, this may not be true for a single dose of DTwP given in early infancy. Furthermore, substitution of the first DTaP dose with DTwP may significantly reduce the frequency of extensive limb swelling observed after the 18 month and 4 year old booster doses of DTaP. An assessment of the immune responses of contemporary Australian infants primed with either a mixed DTwP/DTaP or the current DTaP-only schedule is warranted.

Infants will receive either a combined Diphtheria-Tetanus-whole cell Pertussis, Hepatitis B, and Haemophilus influenzae type B vaccine (DTwP-HepB-Hib) OR a combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type B vaccine (DTaP-HepB-IPV-Hib) as their first vaccine dose at 6- <12 weeks of age as part of the infant vaccine schedule. All infants will then receive DTaP-HepB-IPV-Hib at 4 and 6 months of age and combined Diphtheria-Tetanus-acellular Pertussis (DTPa) and Inactivated Poliovirus at 18 months of age, along with vaccines prescribed by the standard Australian Immunisation Schedule. The dose and route of vaccination will be consistent with the manufacturer’s instruction.

The primary objective of the study is to assess the allergy protective benefits of the addition of DTwP into the infant schedule. Infants will be assessed for development of allergic disease and atopic sensitisation. The study will also assess the reactogenicity profile of the whole cell vaccine within stage 1 and the first 150 participants of stage 2 of this two staged trial. If DTwP is found to be acceptable to parents and protective against the development of atopic disease this could have profound implications for vaccine policy in Australia and around the world.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tom Snelling

Address

Faculty of Medicine and Health,
School of Public Health,
Health and Clinical Analytics
Rm 123, Edward Ford Building
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 401355389

Fax

[email protected]

Contact person for public queries

Name

Tom Snelling

Address

Faculty of Medicine and Health,
School of Public Health,
Health and Clinical Analytics
Rm 123, Edward Ford Building
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 401355389

Fax

[email protected]

Contact person for scientific queries

Name

Tom Snelling

Address

Faculty of Medicine and Health,
School of Public Health,
Health and Clinical Analytics
Rm 123, Edward Ford Building
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 401355389

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All non-identifiable IPD will be made available subject to approval by the Coordinating Principal Investigator and following HREC approval.

When will data be available (start and end dates)?

From 1 month after publication of clinical trial results. No end date determined.

Available to whom?

On a case-by-case basis at the discretion of the Coordinating Principal Investigator, to researchers who provide a methodologically sounds proposal that is approved through the appropriate HREC.

Available for what types of analyses?

Analyses to achieve the aims in the approved proposal only.

How or where can data be obtained?

Access via secure file transfer, subject to approvals by the Coordinating Principal Investigator (Professor Tom Snelling, [email protected]) and appropriate HREC.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22280	Study protocol	Perez Chacon G, Estcourt MJ, Totterdell J, et al. OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule. BMJ Open 2020;10:e042838. doi:10.1136/bmjopen-2020-042838	https://bmjopen.bmj.com/content/10/12/e042838
22281	Statistical analysis plan	Totterdell, J.A., Chacon, G.P., Estcourt, M.J. et al. Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule. Trials 23, 121 (2022). https://doi.org/10.1186/s13063-021-05874-6	https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05874-6

Results publications and other study-related documents

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Source	Title	Year of Publication	DOI
Embase	OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule.	2020	https://dx.doi.org/10.1136/bmjopen-2020-042838
Embase	Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule.	2022	https://dx.doi.org/10.1186/s13063-021-05874-6
Embase	Immunogenicity, reactogenicity, and IgE-mediated immune responses of a mixed whole-cell and acellular pertussis vaccine schedule in Australian infants: a randomised, double-blind, non-inferiority trial.	2023	https://dx.doi.org/10.1101/2023.12.20.23300336

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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