Baby Vaccine Study (Sched3)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-06-30

Brief Summary

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This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will provide information about how best to include the meningococcal B vaccine (likely to be introduced late 2015) into the routine immunisation schedule.

The UK Department of Health provides a routine vaccination schedule for children in the UK and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the current MenC conjugate vaccine dose given at 3 months of age. There is no published immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme.

This change to the schedule would result in three injections at 2, 4 and 12 months, and given previous reluctance among parents for three injections at one visit, an option to reduce PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed in this study.

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Detailed Description

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The study's primary objective is to assess antibody response to the pneumococcal vaccine after the final infant vaccinations at approximately 13 months of age, and secondary objectives include antibody response following meningococcal B and C vaccines, tetanus, diphtheria and pertussis vaccines. In addition, the effect of maternal pertussis vaccination in pregnancy on infant immune response to vaccines, the prevalence of carriage of pneumococcal serotypes at 12 and 18 months of age and reactogenecity following each vaccine will be assessed.

200 healthy children who have not yet received their routine infant immunisations will be enrolled between 8 and 12 weeks old. Participants will be randomised into one of two groups with differing vaccine schedules. Children in both groups will receive their routine immunisations with the following changes: the addition of 3 doses of a meningococcal B vaccine at 2, 4 and 12 months and a meningococcal C vaccine at 12 months only (instead of a dose at 3 and 12 months). The 2 groups will differ by the number of doses of the 13-valent pneumococcal vaccine (PCV13); to be given either at 2, 4, and 12 months of age (as currently given in the routine schedule) or at 3 and 12 months of age.

Each participant will have 2 blood tests: at 5 and 13 months of age, and 2 nose swabs: at 12 and 18 months of age to address the objectives of the study. Parents will be asked to complete a health diary to record any adverse events in the 7 days following vaccinations and a continuous thermometer (ibutton) will be used to record the temperature for 24 hours after each vaccination.

If the blood samples at 13 months reveal antibody titres that are below the level indicative of protection, a recommendation will be made for booster vaccinations.

Conditions

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Infectious Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1 will receive the following interventions:

* DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months
* 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 2, 4 and 12 months
* Rotavirus vaccine oral 1.5ml at 2 and 3 months
* 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months
* Meningococcal C/Hib vaccine IM 0.5ml at 12 months
* Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months

Group Type OTHER

DTaP/IPV/Hib vaccine

Intervention Type BIOLOGICAL

Given at 2, 3 and 4 months to Group 1 and 2

13 valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2

Rotavirus vaccine

Intervention Type BIOLOGICAL

Given at 2 and 3 months to Group 1 and 2

4-component Meningococcal B vaccine

Intervention Type BIOLOGICAL

Given at 2, 4 and 12 months to Group 1 and 2

Meningococcal C/Hib vaccine (MenC/Hib vaccine)

Intervention Type BIOLOGICAL

Given at 12 months to Group1 and 2

Measles/Mumps/Rubella Vaccine (MMR vaccine)

Intervention Type BIOLOGICAL

Given at 13 months to Groups 1 and 2

Group 2

Group 2 will receive the following interventions:

* DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months
* 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 3 and 12 months (instead of current routine schedule of 2,4 and 12 months)
* Rotavirus vaccine oral 1.5ml at 2 and 3 months
* 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months
* Meningococcal C/Hib vaccine IM 0.5ml at 12 months
* Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months

Group Type OTHER

DTaP/IPV/Hib vaccine

Intervention Type BIOLOGICAL

Given at 2, 3 and 4 months to Group 1 and 2

13 valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2

Rotavirus vaccine

Intervention Type BIOLOGICAL

Given at 2 and 3 months to Group 1 and 2

4-component Meningococcal B vaccine

Intervention Type BIOLOGICAL

Given at 2, 4 and 12 months to Group 1 and 2

Meningococcal C/Hib vaccine (MenC/Hib vaccine)

Intervention Type BIOLOGICAL

Given at 12 months to Group1 and 2

Measles/Mumps/Rubella Vaccine (MMR vaccine)

Intervention Type BIOLOGICAL

Given at 13 months to Groups 1 and 2

Interventions

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DTaP/IPV/Hib vaccine

Given at 2, 3 and 4 months to Group 1 and 2

Intervention Type BIOLOGICAL

13 valent Pneumococcal Conjugate Vaccine

Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2

Intervention Type BIOLOGICAL

Rotavirus vaccine

Given at 2 and 3 months to Group 1 and 2

Intervention Type BIOLOGICAL

4-component Meningococcal B vaccine

Given at 2, 4 and 12 months to Group 1 and 2

Intervention Type BIOLOGICAL

Meningococcal C/Hib vaccine (MenC/Hib vaccine)

Given at 12 months to Group1 and 2

Intervention Type BIOLOGICAL

Measles/Mumps/Rubella Vaccine (MMR vaccine)

Given at 13 months to Groups 1 and 2

Intervention Type BIOLOGICAL

Other Intervention Names

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Infanrix-IPV-Hib PCV 13 Prevenar Rotarix Bexsero Menitorix Priorix MMR II

Eligibility Criteria

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Inclusion Criteria

* Infants due to receive their primary immunisations , aged up to 13 weeks on first vaccinations.
* Written informed consent given by mother who is aged \>= 16 years \[NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known\]

Exclusion Criteria

* Bleeding disorder
* Fulfil any of the contraindications to vaccination as specified in The Green Book \[https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book\]:
* At risk of invasive pneumococcal disease (IPD) as defined in the Green Book pneumococcal chapter and those born prior to 37 weeks gestation
* Confirmed anaphylactic reaction to a previous dose of the vaccine, or
* Confirmed anaphylactic reaction to any constituent or excipient of the vaccine(s).
* A confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine) and/or kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the MenB vaccine).
* Latex hypersensitivity (the syringe cap of Bexsero may contain natural rubber latex)

Minimum Eligible Age

8 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes