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

Tracking Information

First Received Date ^ICMJE

June 26, 2006

Last Updated Date

September 28, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

See primary study posting (NCT00345579) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

See posting (NCT no:)

Change History

Complete list of historical versions of study NCT00345683 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence of specific adverse events of new onset of chronic illness(es),rash, and conditions prompting emergency room visits [ Time Frame: From booster dose up to Day 30 after booster vaccination and from booster dose through the end of the 6-month safety follow-up ] [ Designated as safety issue: Yes ]
Occurrence of SAEs. [ Time Frame: From booster dose up to Day 30 after booster vaccination and from booster dose through the end of the 6-month safety follow-up ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety: Hib-MenCY-TT vaccine vs monovalent Hib vaccine with respect to AEs post booster.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

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)

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety Study

Condition ^ICMJE

Haemophilus Influenza b Infections
Meningococcal Infection

Intervention ^ICMJE

Biological: M-M-R II
Biological: Varivax
Biological: PedvaxHIB
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Biological: Prevnar

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4053

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Months to 15 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Mexico

Administrative Information

NCT ID ^ICMJE

NCT00345683

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

105988

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP