Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00492557

First received: June 26, 2007

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Results First Received: January 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Pneumococcal Infections
Interventions:	Biological: 13-valent pneumococcal conjugate vaccine Biological: 13vPnC + TIV

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
A total of 1185 participants were enrolled, of which 1160 were randomized.

Reporting Groups

	Description
13vPnC+TIV Followed by Placebo 1 Month Later	Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
Placebo+TIV Followed by 13vPnC 1 Month Later	Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.

Participant Flow: Overall Study

	13vPnC+TIV Followed by Placebo 1 Month Later	Placebo+TIV Followed by 13vPnC 1 Month Later
STARTED	580	580
Vaccinated Dose 1	577	575
Vaccinated Dose 2	560	558
COMPLETED	556	557
NOT COMPLETED	24	23
Subject request	12	11
Protocol Violation	7	8
Unspecified	2	2
Death	1	1
Adverse Event	1	0
Failed to return	1	0
Lost to Follow-up	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
13vPnC+TIV Followed by Placebo 1 Month Later	Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
Placebo+TIV Followed by 13vPnC 1 Month Later	Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
Total	Total of all reporting groups

Baseline Measures

	13vPnC+TIV Followed by Placebo 1 Month Later	Placebo+TIV Followed by 13vPnC 1 Month Later	Total
Number of Participants [units: participants]	576	575	1151
Age ^[1] [units: years] Mean ± Standard Deviation	72.1 ± 5.6	72.1 ± 5.5	72.1 ± 5.5
Gender ^[1] [units: participants]
Female	289	290	579
Male	287	285	572

[1]	Data for participants in the safety population (ie. those who received at least 1 dose of study vaccine) are presented. The number of participants equals the number receiving Dose 1 in the Participant Flow section (1152), minus 1 participant in the "13vPnC+TIV followed by placebo 1 month later" group who received a regimen that was not part of the study.

Outcome Measures

Show All Outcome Measures

1. Primary:

TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) [ Time Frame: Baseline and 1 month after TIV vaccination ]

Show Outcome Measure 1

2. Primary:

13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 1 month after 13vPnC vaccination ]

Show Outcome Measure 2

3. Other Pre-specified:

Percentage of Participants With Pre-specified Local Reactions [ Time Frame: Days 1 through 14 after 13vPnC vaccination ]

Show Outcome Measure 3

4. Other Pre-specified:

Percentage of Participants With Pre-specified Systemic Events [ Time Frame: Days 1 through 14 after 13vPnC vaccination ]

Show Outcome Measure 4

5. Post-Hoc:

13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) [ Time Frame: 1 month after 13vPnC vaccination ]

Show Outcome Measure 5

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:	Pfizer
ClinicalTrials.gov Identifier:	NCT00492557 History of Changes
Other Study ID Numbers:	6115A1-3008
Study First Received:	June 26, 2007
Results First Received:	January 17, 2012
Last Updated:	January 17, 2012
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

To Top