CompletedPhase 3

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

United States, Mexico4,432 participantsStarted 2006-09

Plain-language summary

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Who can participate

Age range

6 Weeks – 12 Weeks

Sex

ALL

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 for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after 36 weeks gestation. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. * Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Exclusion criteria: 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. * In country(ies) where Prevnar will be provided by GSK Biologicals, previous v…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

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

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of Subjects Reporting Rash

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

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

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

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

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Trial details

NCT IDNCT00345579

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

Results submitted2012-06-15

View on ClinicalTrials.gov More Haemophilus Influenzae Type b trials

Plain-language summary

Who can participate

Age range

6 Weeks – 12 Weeks

Sex

ALL

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 Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

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

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of Subjects Reporting Rash

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

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

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

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

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)