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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00345683
First received: June 26, 2006
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).

No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Meningococcal Infection
Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine
Haemophilus Influenza b Infections
 Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Biological: PedvaxHIB
Biological: Prevnar
Biological: M-M-R II
Biological: Varivax
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) [ Time Frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) ] [ Designated as safety issue: No ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  • Number of Subjects Reporting Rash [ Time Frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) ] [ Designated as safety issue: No ]
    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

  • Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) ] [ Designated as safety issue: No ]
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With New Onset of Chronic Illnesses (NOCIs) [ Time Frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) ] [ Designated as safety issue: No ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  • Number of Subjects With Rash [ Time Frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) ] [ Designated as safety issue: No ]
    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

  • Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) ] [ Designated as safety issue: No ]

Enrollment: 4021
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menhibrix Group
Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
 Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Booster dose by intramuscular injection
Biological: Prevnar
Booster dose by intramuscular injection
Biological: M-M-R II
Single dose by subcutaneous injection
Other Names:
  • Measles
  • mumps and rubella vaccine.
Biological: Varivax
Single dose by subcutaneous injection
Other Name: Varicella vaccine
Active Comparator: ActHIB Group
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
 Biological: PedvaxHIB
Booster dose by intramuscular injection
Other Name: Monovalent Hib conjugate vaccine.
Biological: Prevnar
Booster dose by intramuscular injection
Biological: M-M-R II
Single dose by subcutaneous injection
Other Names:
  • Measles
  • mumps and rubella vaccine.
Biological: Varivax
Single dose by subcutaneous injection
Other Name: Varicella vaccine

Detailed Description:

Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.

The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.

All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

Exclusion Criteria:

Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

  • History of measles, mumps, rubella or varicella.
  • Previous vaccination against measles, mumps, rubella or varicella.
  • Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
  • Patients receiving immunosuppressive therapy.
  • Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Individuals with primary and acquired immunodeficiency states.
  • Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • Individuals with active tuberculosis.
  • Acute disease at time of booster vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345683

  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Primary Study  This link exits the ClinicalTrials.gov site

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00345683     History of Changes
Other Study ID Numbers: 105988
Study First Received: June 26, 2006
Results First Received: June 15, 2012
Last Updated: November 21, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
H. influenzae type B vaccine
Infants
Neisseria meningitidis
Vaccines, conjugate
Meningococcal vaccines
 Prophylaxis
Comparative study
Safety
Humans

Additional relevant MeSH terms:
Haemophilus Infections
Influenza, Human
Meningococcal Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 23, 2013