NCT00109343

Brief Summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,027

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 10, 2010

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

April 27, 2005

Results QC Date

September 23, 2009

Last Update Submit

March 15, 2017

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (11)

  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL

    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<255 mIU/mL) to Measles at Baseline.

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL

    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 ELISA Ab units/mL) to Mumps at Baseline.

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline.

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL

    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

  • Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.

  • Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer

    Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Other Outcomes (7)

  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V

    6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

  • +4 more other outcomes

Study Arms (3)

1

EXPERIMENTAL

Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)

Biological: Comparator: ProQuad™ (V221)Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

2

EXPERIMENTAL

Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)

Biological: Comparator: ProQuad™ (V221)Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

3

EXPERIMENTAL

Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)

Biological: Comparator: ProQuad™ (V221)Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Interventions

Comparator: ProQuad™ (V221)BIOLOGICAL

0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)

Also known as: ProQuad™, V221
123
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)BIOLOGICAL

0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Also known as: PREVNAR™
123

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • In good health
  • to 15 months of age
  • Negative clinical history to measles, mumps, rubella, varicella and/or zoster
  • Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
  • Signed consent

You may not qualify if:

  • Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
  • Any condition resulting in depressed immunity
  • Any allergy to any vaccine component as stated in the package circulars
  • Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
  • History of seizure disorder
  • Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
  • Recent febrile illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schodel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e1387-94. doi: 10.1542/peds.2010-2132. Epub 2011 Nov 28.

    PMID: 22123890RESULT

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

measles, mumps, rubella, varicella vaccinePneumococcal VaccinesHeptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Limitations and Caveats

One subject (Group 3-ProQuad™ followed by PREVNAR™) was diagnosed (Day 8) with Stage IV neuroblastoma (considered not related to study vaccine by investigator) and discontinued from the study. Subject died (Day 218) due to neuroblastoma.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 27, 2005

Study Start

March 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 12, 2017

Results First Posted

February 10, 2010

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

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