Clinical trial NCT00289796: 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
Official title: Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 121
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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".

Eligibility criteria: Inclusion criteria For the primary vaccination phase

* 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 For the primary vaccination phase

* 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."

Primary outcomes:
measure: Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 0
measure: Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 3
measure: Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 5
measure: Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 7
measure: Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 0
measure: Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 3
measure: Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 5
measure: Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 7
measure: Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 1 Post-Booster
measure: Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 1 Post-Booster
measure: Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 7
measure: Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
timeFrame: At Month 1 Post-Booster
measure: Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At Month 7
measure: Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At Month 1 post-booster vaccination
measure: Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At Month 7
measure: Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
timeFrame: At Month 1 post-booster vaccination
measure: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At Month 7
measure: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At Month 1 post-booster vaccination
measure: Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At Month 7
measure: Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
timeFrame: At Month 1 post-booster vaccination
measure: Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At Month 7
measure: Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At Month 1 post-booster vaccination
measure: Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At Month 7
measure: Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At pre-booster vaccination (Month 0 BST)
measure: Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
timeFrame: At Month 1 post-booster vaccination
measure: Number of subjects with solicited general symptoms
timeFrame: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination
measure: Number of subjects with unsolicited adverse events (AES)
timeFrame: Occurring within Day 0-30 following primary and booster vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.