Hepatitis B Vaccination in Infants (Infanrix)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Health Protection Agency, United Kingdom
Sponsor:
Collaborators:
Department of Health, United Kingdom
Institute of Child Health, London, England
Information provided by (Responsible Party):
Dr. Shamez Ladhani, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT01896596
First received: June 13, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
Pneumococcal Disease
Haemophilus Influenzae Serotype b Disease
Diphtheria, Tetanus and Pertussis
Hepatitis b
Biological: Menjugate
Biological: Menitorix
Biological: NeisVac-C
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase IV Study to Evaluate the Primary and Booster Immune Responses of UK Infants Receiving a Licensed 6-in-1 DTaP/IPV/Hib/HBV Vaccine (Infanrix-HexaTM) With a 13-valent Pneumococcal Conjugate Vaccine and Incorporating a Randomisation Study of a Single Dose of 3 Different Meningococcal Group C Conjugate Vaccines at 3 Months of Age

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after primary immunisation [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Proportion of infants achieving MenC SBA titres ≥8 at 4 months of age (one month after a single dose of a MenC-containing vaccine) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after primary immunisation [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Proportion of infants achieving MenC SBA titres ≥128 at 4 months of age (one month after a single dose of a MenC-containing vaccine) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Hib IgG GMCs at one month after primary immunisation schedule [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • MenC SBA GMT at 4 months of age (one month after a single dose of a MenC-containing vaccine) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of infants achieving Hib IgG concentrations ≥0.15 µg/ml at one month after routine 12-month booster vaccinations [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Proportions of infants achieving MenC SBA titres >8 at one month after routine 12-month booster vaccinations [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Proportions of infants achieving Hib IgG concentrations ≥1.00 µg/ml at one month after routine 12-month booster vaccinations [ Time Frame: 13 ] [ Designated as safety issue: No ]
  • Proportions of infants achieving MenC SBA titres >128 at one month after routine 12-month booster vaccinations [ Time Frame: 13 ] [ Designated as safety issue: No ]
  • Hib IgG GMC at one month after routine 12-month booster vaccinations [ Time Frame: 13 ] [ Designated as safety issue: No ]
  • MenC SBA GMT at one month after routine 12-month booster vaccinations [ Time Frame: 13 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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. [ Time Frame: Within 7 days of each vaccination visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Menjugate
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
Administered with routine vaccinations at 3 months of age
Other Name: MenC-CRM
Active Comparator: Menitorix
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
Administered with routine vaccinations at 3 months
Other Name: Hib/MenC-TT
Active Comparator: NeisVac-C
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
Administered with routine vaccinations at 3 months
Other Name: MenC-TT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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
  • Do not fulfil any of the exclusion criteria.

Exclusion Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896596

Contacts
Contact: Shamez Ladhani, MRCPCH PhD shamez.ladhani@phe.gov.uk
Contact: Jo Southern, PhD jo.southern@phe.gov.uk

Locations
United Kingdom
GP surgeries in Gloucestershire Enrolling by invitation
Gloucestershire, United Kingdom
GPs surgeries in Hertfordshire Enrolling by invitation
Hertfordshire, United Kingdom
Sponsors and Collaborators
Health Protection Agency, United Kingdom
Department of Health, United Kingdom
Institute of Child Health, London, England
Investigators
Study Director: Liz Miller, PhD Public Health England
  More Information

No publications provided

Responsible Party: Dr. Shamez Ladhani, Paediatric Infectious Disease Consultant, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT01896596     History of Changes
Other Study ID Numbers: RSRSG 12-03
Study First Received: June 13, 2013
Last Updated: July 8, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Department of Health

Keywords provided by Health Protection Agency, United Kingdom:
vaccines
immunogenicity
adverse reactions

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Meningococcal Infections
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Infection
Clostridium Infections

ClinicalTrials.gov processed this record on September 14, 2014