Trial Outcomes & Findings for Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED) (NCT NCT00326183)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1800 participants

Primary outcome timeframe

Days 1 to 14 after any vaccination

Results posted on

2019-02-04

Participant Flow

18 investigators in the United States; Date of first subject visit: 26-Mar-2007. Date of last subject visit: 14-Nov-2007.

Participant milestones

Participant milestones
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Study STARTED	1453	347
Overall Study Vaccination 1 + Safety Follow-up	1453	347
Overall Study Postvaccination 1 Post-safety Follow-up	1393	325
Overall Study Vaccination 2 + Safety Follow-up	1301	292
Overall Study Postvaccination 2 Post-safety Follow-up	1265	271
Overall Study COMPLETED	1253	264
Overall Study NOT COMPLETED	200	83

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Overall Study Lost to Follow-up	104	56
Overall Study Protocol Violation	6	3
Overall Study Withdrawal by Subject	35	7
Overall Study Subject Moved	7	4
Overall Study Other	47	13
Overall Study Adverse Event	1	0

Baseline Characteristics

Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: VAQTA™ n=1453 Participants Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=347 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live	Total n=1800 Participants Total of all reporting groups
Age, Continuous	13.3 months STANDARD_DEVIATION 1.49 • n=5 Participants	12.5 months STANDARD_DEVIATION 0.90 • n=7 Participants	13.2 months STANDARD_DEVIATION 1.43 • n=5 Participants
Sex: Female, Male Female	703 Participants n=5 Participants	176 Participants n=7 Participants	879 Participants n=5 Participants
Sex: Female, Male Male	750 Participants n=5 Participants	171 Participants n=7 Participants	921 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 to 14 after any vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ n=1415 Participants Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=334 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With 1 or More Serious Vaccine-Related Adverse Experiences	0 participants	1 participants

PRIMARY outcome

Timeframe: Days 1 to 14 after any vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ n=1415 Participants Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=334 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With 1 or More Injection-Site Adverse Experiences	701 participants	164 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=328 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Measles-Like Rash After First Vaccination	—	13 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=263 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Measles-Like Rash After Second Vaccination	—	5 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=328 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Mumps-Like Symptoms After First Vaccination	—	0 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=263 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Mumps-Like Symptoms After Second Vaccination	—	0 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=328 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Rubella-Like Rash After First Vaccination	—	1 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=263 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Rubella-Like Rash After Second Vaccination	—	0 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After First Vaccination

Population: Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=328 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Varicella/Zoster-Like Rash After First Vaccination	—	0 participants

PRIMARY outcome

Timeframe: Days 1 to 28 After Second Vaccination

Population: Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=263 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Varicella/Zoster-Like Rash After Second Vaccination	—	0 participants

PRIMARY outcome

Timeframe: Days 1 to 5 After Any Vaccination

Population: Includes all subjects who provided body temperature follow-up data after any dose of vaccine.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ n=1383 Participants Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=320 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With Elevated Temperature (>=102.2F/39.0C)	56 participants	13 participants

SECONDARY outcome

Timeframe: Days 1 to 14 After Any Vaccination

Population: Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.

Outcome measures

Outcome measures
Measure	Arm 1: VAQTA™ n=1415 Participants Hepatitis A vaccine, inactivated	Arm 2: VAQTA™ +ProQuad™ n=334 Participants Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
Participants With 1 or More Systemic Adverse Experiences	782 participants	197 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Clinical and Quantitative Sciences

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER