Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants

NCT00586612 | Completed Phase 3 Results

• 2 other identifiers: 110215110217
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) \& Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis

Keywords

Conjugate vaccine; Persistence; Hib vaccine; Combination vaccine; Meningococcal vaccine; Safety; Preterm/full-term infants; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)

  Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.

  One month after the third vaccination

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8

  rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.

  One month after the third vaccination

Secondary Outcomes (29)

• Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values

  Before vaccination (at Day 0)

• Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter

  One month after the third vaccination

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values

  Before vaccination (at Day 0)

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values

  One month after the third vaccination

• Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values

  Before vaccination (at Day 0)

Study Arms (2)

Preterm group

EXPERIMENTAL

Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.

Biological: Menitorix™; Biological: Infanrix™ penta; Biological: Prevenar™; Biological: Infanrix™ IPV

Full-term group

ACTIVE COMPARATOR

Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.

Biological: Menitorix™; Biological: Infanrix™ penta; Biological: Prevenar™; Biological: Infanrix™ IPV

Interventions

Menitorix™ BIOLOGICAL

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

Full-term group; Preterm group

Infanrix™ penta BIOLOGICAL

Intramuscular injection, 3 doses in the primary study

Full-term group; Preterm group

Prevenar™ BIOLOGICAL

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

Full-term group; Preterm group

Infanrix™ IPV BIOLOGICAL

Intramuscular injection, 1 dose in the Booster study.

Full-term group; Preterm group

Eligibility Criteria

• Age: 8 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All subjects must satisfy the following criteria at study entry:
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• All preterm subjects must satisfy the following criteria at study entry:
• Born after a gestation period of less than or equal to 36 weeks (≤258 days).
• Medically stable, i.e. do not require significant medical support or ongoing management for debilitating disease and have demonstrated a clinical course of sustained recovery.
• All full-term subjects must satisfy the following criteria at study entry:
• Born after a gestation period between and including 37 and 42 weeks (≥259 days and ≤294 days).
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine until the last study visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given according to local immunisation practices and except rotavirus oral vaccine which is allowed at anytime during the study after hospital discharge as per prescribing information.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in the first month of life according to the national recommendations (although BCG and hepatitis B vaccines should have been given outside a 30-day window from the first administration of study vaccines).
• History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins (with the exception of monoclonal antibodies against respiratory syncytial virus \[RSV\]) and/or any blood products within one month (30 days) preceding the first dose of study vaccines.
• Planned administration of immunoglobulins and/or any blood products during the active phase of the study.
• Specific criteria for the booster part of the study (to be checked at Visit 5, study month 14):
• History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Getafe, 28905, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

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

Haemophilus Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: December 1, 2007
• Primary Completion: December 30, 2008
• Study Completion: December 30, 2008
• Last Updated: August 27, 2018
• Results First Posted: January 22, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (8)