Hepatitis B Vaccination in Infants

NCT01896596 | Completed Phase 4

• 1 other identifier: RSRSG 12-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vaccines; immunogenicity; adverse reactions

Outcome Measures

Primary Outcomes (6)

• Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after primary immunisation

  5 months

• Proportion of infants achieving MenC SBA titres ≥8 at 4 months of age (one month after a single dose of a MenC-containing vaccine)

  4 months

• Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after primary immunisation

  5 months

• Proportion of infants achieving MenC SBA titres ≥128 at 4 months of age (one month after a single dose of a MenC-containing vaccine)

  4 months

• Hib IgG GMCs at one month after primary immunisation schedule

  5 months

• MenC SBA GMT at 4 months of age (one month after a single dose of a MenC-containing vaccine)

  4 months

Secondary Outcomes (6)

• Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after routine 12-month booster vaccinations

  13 months

• Proportions of infants achieving MenC SBA titres >8 at one month after routine 12-month booster vaccinations

  13 months

• Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after routine 12-month booster vaccinations

  13

• Proportions of infants achieving MenC SBA titres >128 at one month after routine 12-month booster vaccinations

  13

• Hib IgG GMC at one month after routine 12-month booster vaccinations

  13

Other Outcomes (1)

• Percentage of children experiencing fever, local reactions, non-febrile systemic reactions and other expected and unexpected adverse events during the 7 days following each vaccine dose.

  Within 7 days of each vaccination visit

Study Arms (3)

Menjugate

ACTIVE COMPARATOR

Infants will receive intramuscular Infanrix Hexa (at 2-3-4 months) with Menjugate (at 3 months), Prevenar13 (at 2-4 months) and oral rotarix (at 2 and 3 months) vaccines

Biological: Menjugate

Menitorix

ACTIVE COMPARATOR

Infants will receive intramuscular Infanrix Hexa (at 2-3-4 months) with Menitorix (at 3 months), Prevenar13 (at 2-4 months) and oral rotarix (at 2 and 3 months) vaccines

Biological: Menitorix

NeisVac-C

ACTIVE COMPARATOR

Infants will receive intramuscular Infanrix Hexa (at 2-3-4 months) with NeisVac-C(at 3 months), Prevenar13 (at 2-4 months) and oral rotarix (at 2 and 3 months) vaccines

Biological: NeisVac-C

Interventions

Menjugate BIOLOGICAL

Administered with routine vaccinations at 3 months of age

Also known as: MenC-CRM

Menjugate

Menitorix BIOLOGICAL

Administered with routine vaccinations at 3 months

Also known as: Hib/MenC-TT

Menitorix

NeisVac-C BIOLOGICAL

Administered with routine vaccinations at 3 months

Also known as: MenC-TT

NeisVac-C

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female infants born at term (at least 37 weeks gestation) who are aged \<12 weeks and have not yet received their primary immunisations
• With written informed consent obtained from the parent or legal guardian of the infant to participate in the study

You may not qualify if:

• Participant may not be included in the study if any of the following apply:
• History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B
• History of maternal acute or chronic hepatitis B infection
• Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
• Bleeding disorders and/or prolonged bleeding time
• Major congenital defects or chronic disease
• Premature birth (\<37 weeks gestation at birth).
• Previously received any vaccine (particularly hepatitis B)

Sponsors & Collaborators

• Public Health England: lead
• Department of Health, United Kingdom: collaborator
• Institute of Child Health, London, England: collaborator

Study Sites (1)

St George's Vaccien Institute

London, United Kingdom

Location

MeSH Terms

Conditions

Meningococcal Infections; Pneumococcal Infections; Diphtheria; Tetanus; Whooping Cough; Hepatitis B

Interventions

MenC-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Clostridium Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Elizabeth Coates, PhD

  Public Health England

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 1, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)