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

NCT00289796 | Completed Phase 2

• 2 other identifiers: 210602-002105752
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (32)

• Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  At Month 0

• Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  At Month 3

• Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  At Month 5

• Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  At Month 7

• Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  At Month 0

• Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  At Month 3

• Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  At Month 5

• Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  At Month 7

• Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

  At Month 1 Post-Booster

• Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

  At Month 1 Post-Booster

• Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

  At Month 7

• Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

  At Month 1 Post-Booster

• Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  At Month 7

• Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  At pre-booster vaccination (Month 0 BST)

• Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  At Month 1 post-booster vaccination

• Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  At Month 7

• Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  At pre-booster vaccination (Month 0 BST)

• Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

  At Month 1 post-booster vaccination

• Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  At Month 7

• Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  At pre-booster vaccination (Month 0 BST)

• Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

  At Month 1 post-booster vaccination

• Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  At Month 7

• Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  At pre-booster vaccination (Month 0 BST)

• Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

  At Month 1 post-booster vaccination

• Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  At Month 7

• Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  At pre-booster vaccination (Month 0 BST)

• Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

  At Month 1 post-booster vaccination

• Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  At Month 7

• Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  At pre-booster vaccination (Month 0 BST)

• Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

  At Month 1 post-booster vaccination

• Number of subjects with solicited general symptoms

  The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = \> 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.

  During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination

• Number of subjects with unsolicited adverse events (AES)

  An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Occurring within Day 0-30 following primary and booster vaccination

Study Arms (1)

Infanrix hexa Group

ACTIVE COMPARATOR

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.

Biological: DTPa-HBV-IPV/Hib

Interventions

DTPa-HBV-IPV/Hib BIOLOGICAL

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

Infanrix hexa Group

Eligibility Criteria

• Age: 2 Days - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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."

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (2)

• 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.

  PMID: 18410769 BACKGROUND

• 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.

  PMID: 20303444 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: July 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: December 1, 2006
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)