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Baby Vaccine Study (Sched3)

NCT02482636 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2021-09-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

DTaP/IPV/Hib vaccine

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

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

BIOLOGICAL

Rotavirus vaccine

Given at 2 and 3 months to Group 1 and 2

BIOLOGICAL

4-component Meningococcal B vaccine

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

BIOLOGICAL

Meningococcal C/Hib vaccine (MenC/Hib vaccine)

Given at 12 months to Group1 and 2

BIOLOGICAL

Measles/Mumps/Rubella Vaccine (MMR vaccine)

Given at 13 months to Groups 1 and 2

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Matthew D Snape · Oxford Vaccine Group, Chief Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-11-01
Completion
2021-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482636 on ClinicalTrials.gov