Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00676091

First received: April 8, 2008

Last updated: August 4, 2011

Last verified: August 2011

History of Changes

Results First Received: September 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Prevention
Condition:	Vaccines, Pneumococcal Conjugate Vaccine
Interventions:	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Participant Flow for 3 periods

Period 1: Infant Series

	13vPnC	7vPnC
STARTED	177	177
Vaccinated Dose 1	163	162
Vaccinated Dose 2	159	162
Vaccinated Dose 3	158	161
COMPLETED	157	159
NOT COMPLETED	20	18
Parent or legal guardian request	10	8
Protocol Violation	6	3
Adverse Event	2	3
Failed to return	1	3
Lost to Follow-up	1	0
Died prior to receiving 7vPnC	0	1

Period 2: After Infant Series

	13vPnC	7vPnC
STARTED	157	159
COMPLETED	156	156
NOT COMPLETED	1	3
Adverse Event	0	1
Protocol Violation	0	1
Failed to return	1	1

Period 3: Toddler Dose

	13vPnC	7vPnC
STARTED	156	156
COMPLETED	153	156
NOT COMPLETED	3	0
Failed to return	2	0
Parent or legal guardian request	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Total	Total of all reporting groups

Baseline Measures

	13vPnC	7vPnC	Total
Number of Participants [units: participants]	163	162	325
Age [units: months] Mean ± Standard Deviation	2.2 ± 0.2	2.2 ± 0.2	2.2 ± 0.2
Gender [units: participants]
Female	89	76	165
Male	74	86	160

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 Month after the infant series (7 Months of age) ]

Show Outcome Measure 1

2. Primary:

Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 2

3. Secondary:

Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Show Outcome Measure 3

4. Secondary:

Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Show Outcome Measure 4

5. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

Show Outcome Measure 5

6. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

Show Outcome Measure 6

7. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

Show Outcome Measure 7

8. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

Show Outcome Measure 8

9. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

Show Outcome Measure 9

10. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

Show Outcome Measure 10

11. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

Show Outcome Measure 11

12. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

Show Outcome Measure 12

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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00676091 History of Changes
Other Study ID Numbers:	6096A1-012
Study First Received:	April 8, 2008
Results First Received:	September 22, 2010
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

To Top