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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289796
• Other study ID #: 210602-002
• Secondary ID: 105752
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: February 6, 2017
• Start date: July 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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."

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• DTPa-HBV-IPV/Hib
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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

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