Hepatitis B Vaccination in Infants

Summary

In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps protect against hepatitis B alongside the other routine vaccinations in the UK infant immunisation schedule and assess their immune responses to the different vaccines. Hepatitis B virus infects the liver and usually affects adults, but children can be infected through close contact with carriers of the virus. Children with hepatitis B infection may not have symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many other countries already use Infanrix-Hexa and this study is being undertaken to help decide whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa instead of Pediacel. All other vaccines given will be the same as in the routine schedule but will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule is soon going to change so that all babies will receive only one MenC vaccine at 3 months of age.

There are currently several licensed MenC vaccines that can be given to babies. In order to check whether there are differences in protection, babies taking part will randomly receive one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response to MenC compared to the other two MenC vaccines, although all infants should be well-protected after their 12-month booster vaccinations, which also contain Menitorix.

Conditions

• Meningococcal Disease
• Pneumococcal Disease
• Haemophilus Influenzae Serotype b Disease
• Diphtheria, Tetanus and Pertussis
• Hepatitis b

Interventions

BIOLOGICAL

Menjugate

Administered with routine vaccinations at 3 months of age

BIOLOGICAL

Menitorix

Administered with routine vaccinations at 3 months

BIOLOGICAL

NeisVac-C

Administered with routine vaccinations at 3 months

Sponsors & Collaborators

• Department of Health, United Kingdom

  collaborator OTHER_GOV

• Institute of Child Health, London, England

  collaborator UNKNOWN

• Public Health England

  lead OTHER_GOV

Principal Investigators

• Elizabeth Coates, PhD · Public Health England

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2017-04-30

Completion

2017-04-30

Countries

• United Kingdom

Study Locations