Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

Haemophilus Influenzae Type b Clinical Trial

Official title:

Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327184
• Other study ID #: 106388
• Secondary ID: 106390
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2006
• Last updated: October 6, 2016
• Start date: April 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.

The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria

Primary Phase:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

• healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.

• Written informed consent obtained from the parent or guardian of the subject prior to the study entry.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Booster Phase:

• Participation in primary phase of study.

Exclusion Criteria

Primary Phase:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.

• Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.

• Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease

• History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.

• A family history of congenital or hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures.

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional Exclusion criteria for the Booster Phase:

• Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Intervention

Biological:
• Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
• Infanrix Penta
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
• Infanrix hexa
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
• Neis-Vac-C
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kotka
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vantaa
Finland	GSK Investigational Site	Vantaa
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Lodi	Lombardia
Italy	GSK Investigational Site	Ragusa	Sicilia
Italy	GSK Investigational Site	Sassari	Sardegna

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Finland,  Italy, 

References & Publications (1)

Vesikari T, Forstén A, Desole MG, Ferrera G, Caubet M, Mesaros N, Boutriau D. A combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: results of an open, randomized, controlled study. Pediatr Infect Dis J. 2013 May;32(5):521-9. doi: 10.1097/INF.0b013e31827e22e3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SBA-MenC titre		One month after the second dose of the Primary Vaccination Phase.	No
Primary	Anti-PRP concentration		One month after the second dose of the Primary Vaccination Phase	No
Secondary	SBA-MenC titres		One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination	No
Secondary	Anti-PRP concentrations		One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination	No
Secondary	Anti-PSC concentrations		One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.	No
Secondary	Anti-HBs concentrations		One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination	No
Secondary	Occurrence of local solicited adverse events.		During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.	No
Secondary	Occurrence of solicited general adverse events		During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.	No
Secondary	Occurrence of unsolicited non-serious adverse events		Within 30 days after each vaccination	No
Secondary	Occurrence of any serious adverse events		Throughout the study.	No

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