Skip to main content
OpenTrials
Completed

NCT Number: NCT00345683

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Neisseria Meningitidis Pasteurellaceae Infections

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mexico City, Mexico

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)

Biological

Booster dose by intramuscular injection

PedvaxHIB

Biological

Booster dose by intramuscular injection

Other names: Monovalent Hib conjugate vaccine.

Prevnar

Biological

Booster dose by intramuscular injection

M-M-R II

Biological

Single dose by subcutaneous injection

Other names: Measles, mumps and rubella vaccine.

Varivax

Biological

Single dose by subcutaneous injection

Other names: Varicella vaccine

Primary outcomes

  1. 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)

    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.

  2. 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)

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  3. 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)

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

  4. 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)

  5. 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)

    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.

  6. 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)

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  7. 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)

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

  8. 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 28, 2006
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.