CompletedPhase 3

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

United States4,021 participantsStarted 2007-07

Plain-language 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.

Who can participate

Age range12 Months – 15 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting Rash

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: 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)

Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

Timeframe: 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)

Trial details

NCT IDNCT00345683

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2012-06-15

View on ClinicalTrials.gov More Haemophilus Influenzae Type b trials

Plain-language summary

Who can participate

Age range12 Months – 15 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting Rash

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: 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)

Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

Timeframe: 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)