V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Measles Mumps Rubella Varicella
Interventions:	Biological: Comparator: ProQuad™ (V221) Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
24 clinical sites in the United States Date first participant visit: 06-Mar-2006 Date last participant visit: 14-Sep-2007

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

24 clinical sites in the United States

Date first participant visit: 06-Mar-2006

Date last participant visit: 14-Sep-2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Group 1 - ProQuad™ + PREVNAR™	Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Group 2 - PREVNAR™ Followed by ProQuad™	Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
Group 3 - ProQuad™ Followed by PREVNAR™	Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.

Participant Flow: Overall Study

	Group 1 - ProQuad™ + PREVNAR™	Group 2 - PREVNAR™ Followed by ProQuad™	Group 3 - ProQuad™ Followed by PREVNAR™
STARTED	510	258	259
Vaccinated at Visit 1	510	258	259
Vaccinated at Visit 2	0 ^[1]	246	246
Vaccinated at Visit 4	466	235	240
COMPLETED	446	221	229
NOT COMPLETED	64	37	30
Adverse Event	1	0	2
Lack of Efficacy	1	0	0
Lost to Follow-up	35	20	14
Protocol Violation	1	2	2
Withdrawal by Subject	15	11	10
Subject Moved	6	2	1
Unspecified	5	2	1

[1]	Per-protocol, subjects in Group 1 were not vaccinated at Visit 2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Group 1 - ProQuad™ + PREVNAR™	Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Group 2 - PREVNAR™ Followed by ProQuad™	Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
Group 3 - ProQuad™ Followed by PREVNAR™	Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Total	Total of all reporting groups

Baseline Measures

	Group 1 - ProQuad™ + PREVNAR™	Group 2 - PREVNAR™ Followed by ProQuad™	Group 3 - ProQuad™ Followed by PREVNAR™	Total
Number of Participants [units: participants]	510	258	259	1027
Age [units: Months] Mean ± Standard Deviation	12.6 ± 0.96	12.5 ± 0.93	12.6 ± 0.98	12.6 ± 0.96
Gender [units: participants]
Female	230	120	117	467
Male	280	138	142	560
Race/Ethnicity, Customized [units: participants]
Asian	18	5	8	31
Black	83	36	36	155
Hispanic	46	31	26	103
White	335	161	174	670
Other	28	25	15	68

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

Show Outcome Measure 1

2. Primary:

Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

Show Outcome Measure 2

3. Primary:

Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

Show Outcome Measure 3

4. Primary:

Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

Show Outcome Measure 4

5. Primary:

Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 5

6. Primary:

Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone. ]

Show Outcome Measure 6

7. Primary:

Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 7

8. Primary:

Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 8

9. Primary:

Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 9

10. Primary:

Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 10

11. Primary:

Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 11

12. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 4 [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 12

13. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 6B [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 13

14. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 9V [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 14

15. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 14 [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 15

16. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 18C [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 16

17. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 19F [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 17

18. Other Pre-specified:

Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 Mcg/mL for S. Pneumoniae Serotype 23F [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

Show Outcome Measure 18

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00109343 History of Changes
Other Study ID Numbers:	2005_027, V221-019
Study First Received:	April 27, 2005
Results First Received:	September 23, 2009
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration