Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine

NCT ID: NCT00289796

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-12-31

Brief Summary

This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.

Detailed Description

"There will be two groups in this study:

• one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
• the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Infanrix hexa Group

Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh.

Group Type: ACTIVE_COMPARATOR

DTPa-HBV-IPV/Hib

Intervention Type: BIOLOGICAL

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

Interventions

DTPa-HBV-IPV/Hib

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination & written informed consent taken from the parents/guardians of the subject
• Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
• Birth weight >= 2.5 kg and 5 minute Apgar >= 7
• Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
• A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria

• Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
• Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
• Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
• Administration of immunoglobulins and/or any blood products to the mother during pregnancy
• Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
• At risk of pneumococcal disease or planning to receive Prevenar™ during the study period
• Administration or planned administration of BCG vaccination during the study period
• Acute disease at the time of vaccination. For the booster vaccination phase
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase.
• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

Knuf M, Schmitt HJ, Wolter J, Schuerman L, Jacquet JM, Kieninger D, Siegrist CA, Zepp F. Neonatal vaccination with an acellular pertussis vaccine accelerates the acquisition of pertussis antibodies in infants. J Pediatr. 2008 May;152(5):655-60, 660.e1. doi: 10.1016/j.jpeds.2007.09.034. Epub 2007 Nov 19.

Reference Type: BACKGROUND

PMID: 18410769 (View on PubMed)

Knuf M, Schmitt HJ, Jacquet JM, Collard A, Kieninger D, Meyer CU, Siegrist CA, Zepp F. Booster vaccination after neonatal priming with acellular pertussis vaccine. J Pediatr. 2010 Apr;156(4):675-8. doi: 10.1016/j.jpeds.2009.12.019.

Reference Type: BACKGROUND

PMID: 20303444 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

105752

Identifier Type: OTHER

Identifier Source: secondary_id

210602-002

Identifier Type: -

Identifier Source: org_study_id