Hepatitis A VirusPhase 4NCT00312858

Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

A Phase 4 study testing Comparator: VAQTA™ (Hepatitis A vaccine), Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) and Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) in people with Hepatitis A Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose. Read more about this study

Who is it for?: Ages 12 to 15 monthsHealthy volunteers can take part
Conditions the study is for: Hepatitis A Virus
What is being tested?: Comparator: VAQTA™ (Hepatitis A vaccine), Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) and Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 653 participants
Where: No sites listed yet
Study dates: Apr 2006to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 15 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

12- to 15-month-old males and females with no active liver disease
A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Who cannot join

Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
Any immune deficiency
History of allergy to any of the vaccine components
History of any seizure disorder

About this study

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age

Read the detailed description

Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.

Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Conditions: Hepatitis A Virus
Being tested: Comparator: VAQTA™ (Hepatitis A vaccine), Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine), Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Keywords: Hepatitis A Virus
Medical subject headings: Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: VAQTA™ (Hepatitis A vaccine)Biological
VAQTA™ 0.5 mL injection
Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)Biological
ProQuad™ 0.5 mL injection
Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)Biological
Prevnar™ 0.5 mL injection

Study groups in NCT00312858
Study group	Role	What they receive
1	Active comparator	Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration. Receives: Biological: Comparator: VAQTA™ (Hepatitis A vaccine); Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
2	Active comparator	Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration. Receives: Biological: Comparator: VAQTA™ (Hepatitis A vaccine); Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Response to Hepatitis A - Participants With a Serological Response
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Measured: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Antibody Response to Varicella - Participants With a Serological Response
Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Measured: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Measured: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Participants With 1 or More Systemic Adverse Experience
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Measured: 6 weeks post dose 1
Participants With 1 or More Systemic Adverse Experience
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Measured: 4 weeks post dose 2
Participants With 1 or More Systemic Adverse Experience.
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Measured: 6 months
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Measured: 6 weeks post dose 1
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Measured: 4 weeks post dose 2
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Measured: 6 months
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Measured: 6 weeks post dose 1
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Measured: 4 weeks post dose 2
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Measured: 6 months
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Measured: 6 weeks post dose 1
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Measured: 4 weeks post dose 2
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Mar 2008

First posted11 Apr 2006 (estimated)
Study startApr 2006
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis A VirusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 653 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00312858
Sponsor's protocol ID: V251-067
Other IDs: 2005_075
Status last verified: Mar 2017
First submitted: 7 Apr 2006
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.
PubMed 23744509

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

All Hepatitis A Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
ClinicalTrials.gov ID: NCT00312858
Acronym / sponsor ID: V251-067
Conditions: Hepatitis A Virus
Keywords: Hepatitis A Virus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 653 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 11 Apr 2006 (estimated)
Results: Posted 3 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Biological: Comparator: VAQTA™ (Hepatitis A vaccine), Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine), Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
2	Active comparator	Biological: Comparator: VAQTA™ (Hepatitis A vaccine), Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine), Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.

Who may qualify

Ages: 12 to 15 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

12- to 15-month-old males and females with no active liver disease
A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Key exclusion criteria (4 listed)

Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
Any immune deficiency
History of allergy to any of the vaccine components
History of any seizure disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: VAQTA™ (Hepatitis A vaccine)VAQTA™ 0.5 mL injection	Biological	1, 2
Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)ProQuad™ 0.5 mL injection	Biological	1, 2
Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)Prevnar™ 0.5 mL injection	Biological	1, 2

Primary outcome

Antibody Response to Hepatitis A - Participants With a Serological Response
Time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Antibody Response to Varicella - Participants With a Serological Response
Time frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Time frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Participants With 1 or More Systemic Adverse Experience
Time frame: 6 weeks post dose 1
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Participants With 1 or More Systemic Adverse Experience
Time frame: 4 weeks post dose 2
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Participants With 1 or More Systemic Adverse Experience.
Time frame: 6 months
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Participants With 1 or More Injection-site Adverse Experience
Time frame: 6 weeks post dose 1
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With 1 or More Injection-site Adverse Experience
Time frame: 4 weeks post dose 2
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With 1 or More Injection-site Adverse Experience
Time frame: 6 months
Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Time frame: 6 weeks post dose 1
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Time frame: 4 weeks post dose 2
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Time frame: 6 months
Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With 1 or More Serious Vaccine-related Adverse Experience
Time frame: 6 weeks post dose 1
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Participants With 1 or More Serious Vaccine-related Adverse Experience
Time frame: 4 weeks post dose 2
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Participants With 1 or More Serious Vaccine-related Adverse Experience
Time frame: 6 months
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

Results and safety

Results posted to the registry on 3 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	330	262
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	323	230

Primary outcome: Antibody Response to Hepatitis A - Participants With a Serological Response

Time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™). Number. Unit: Participants

Measure	Arm 1: VAQTA™ + ProQuad™ + Prevnar™ n = 182	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ n = 159
Value	182	158

Arm 1: VAQTA™ + ProQuad™ + Prevnar™ vs Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™: Risk Difference (RD): 0.7 (95% CI -1.4 to 3.8), p <0.001, Miettinen and Nurminen

Population analysed: Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.

Primary outcome: Antibody Response to Varicella - Participants With a Serological Response

Time frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™). Number. Unit: Participants

Measure	Arm 1: VAQTA™ + ProQuad™ + Prevnar™ n = 225	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ n = 232
Number of participants ≥1.25 gpELISA units/mL	222	231
Number of participants ≥5 gpELISA units/mL	210	228

Arm 1: VAQTA™ + ProQuad™ + Prevnar™ vs Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™: Risk Difference (RD): -5.1 (95% CI -9.3 to -1.4), p = 0.013, Miettinen and Nurminen

Population analysed: Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.

Primary outcome: Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers

Time frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™). Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	Arm 1: VAQTA™ + ProQuad™ + Prevnar™ n = 330	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ n = 323
Serotype 4 (n=246, 247)	1.8 (1.6 to 2.1)	1.6 (1.4 to 1.8)
Serotype 6B (n=246, 246)	9.5 (8.3 to 11.0)	9.6 (8.5 to 10.8)
Serotype 9V (n=247, 247)	3.7 (3.2 to 4.2)	4.1 (3.7 to 4.7)
Serotype 14 (n=248, 247)	7.7 (6.8 to 8.8)	7.4 (6.5 to 8.4)
Serotype 18C (n=247, 247)	2.9 (2.6 to 3.3)	2.6 (2.3 to 3.0)
Serotype 19F (n=248, 248)	4.0 (3.5 to 4.5)	3.8 (3.3 to 4.3)
Serotype 23F (n=247, 247)	4.9 (4.3 to 5.6)	4.5 (3.9 to 5.1)

Arm 1: VAQTA™ + ProQuad™ + Prevnar™ vs Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™: Response ratio (Arm 1 / Arm 2): 1.1 (95% CI 0.9 to 1.3), p <0.001, ANCOVA
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ vs Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™: Response ratio (Arm 1 / Arm 2): 1.0 (95% CI 0.8 to 1.2), p <0.001, ANCOVA
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ vs Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™: Response ratio (Arm 1 / Arm 2): 0.9 (95% CI 0.8 to 1.0), p <0.001, ANCOVA

Population analysed: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures

Primary outcome: Participants With 1 or More Systemic Adverse Experience

Time frame: 6 weeks post dose 1. Number. Unit: Participants

Measure	Arm 1: VAQTA™ + ProQuad™ + Prevnar™ n = 311	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ n = 274
Value	178	80

Population analysed: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	2 of ?	231 of ?	Not reported
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	6 of ?	172 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23744509Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Response to Hepatitis A - Participants With a Serological Response (time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00312858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.