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Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00488826
Recruitment Status : Completed
First Posted : June 20, 2007
Results First Posted : May 27, 2009
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Interventions Biological: 7-valent pneumococcal conjugate vaccine
Biological: Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)
Enrollment 800

Recruitment Details Subjects were recruited in China from September 2006 to May 2007.
Pre-assignment Details Subjects were enrolled into study according to inclusion/exclusion criteria without a screening period.
Arm/Group Title 7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Hide Arm/Group Description 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age. 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age. DTaP administered at 3, 4, and 5 months of age.
Period Title: Overall Study
Started 300 296 204
Completed 244 244 178
Not Completed 56 52 26
Reason Not Completed
Withdrawal by Subject             40             35             19
Protocol Violation             0             0             2
Adverse Event             9             15             4
Lost to Follow-up             5             1             0
Protocol Deviations             2             1             1
Arm/Group Title 7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone Total
Hide Arm/Group Description 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age. 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age. DTaP administered at 3, 4, and 5 months of age. Total of all reporting groups
Overall Number of Baseline Participants 300 296 204 800
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Standard Deviation)
Unit of measure:  Months
Number Analyzed 300 participants 296 participants 204 participants 800 participants
3.5  (1.0) 3.5  (1.0) 3.5  (1.7) 3.5  (1.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 296 participants 204 participants 800 participants
Female
142
  47.3%
133
  44.9%
81
  39.7%
356
  44.5%
Male
158
  52.7%
163
  55.1%
123
  60.3%
444
  55.5%
1.Primary Outcome
Title Concentration of Serotype-Specific IgG Antibodies
Hide Description Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).
Time Frame 7 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population analyzed was available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post-third dose serum available for assessment) and were in either the "7vPnC separately" or "DTaP alone" group. The "7vPnC + DTaP" group was not part of the primary objective; no statistical testing was done.
Arm/Group Title 7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Hide Arm/Group Description:
7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP administered at 3, 4, and 5 months of age.
Overall Number of Participants Analyzed 64 0 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/ml
Serotype 4
15.26
(12.51 to 18.61)
0.01
(0.01 to 0.02)
Serotype 6B
3.1
(2.15 to 4.46)
0.06
(0.04 to 0.08)
Serotype 9V
6.82
(5.65 to 8.23)
0.06
(0.05 to 0.09)
Serotype 14
17.75
(13.53 to 23.28)
0.14
(0.09 to 0.22)
Serotype 18C
6.24
(5.07 to 7.69)
0.03
(0.02 to 0.04)
Serotype 19F
11.77
(8.91 to 15.54)
0.07
(0.05 to 0.10)
Serotype 23F
4.7
(3.22 to 6.86)
0.05
(0.03 to 0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1097
Confidence Interval 90%
793.6 to 1461
Estimation Comments This analysis is for Serotype 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 54.6
Confidence Interval 90%
35.36 to 85.49
Estimation Comments This analysis is for Serotype 6B.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 99.48
Confidence Interval 90%
79.81 to 142.0
Estimation Comments This analysis is for Serotype 9V
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 134.3
Confidence Interval 90%
80.83 to 197.1
Estimation Comments This analysis is for Serotype 14.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 200.3
Confidence Interval 90%
151.9 to 302.4
Estimation Comments This analysis is for Serotype 18C.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 181.3
Confidence Interval 90%
119.8 to 253.1
Estimation Comments This analysis is for Serotype 19F.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 7vPnC Separately, DTaP Alone
Comments The ratio of the "7vPnC Separately" group to the "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 90.02
Confidence Interval 90%
57.93 to 150.5
Estimation Comments This analysis is for Serotype 23F.
2.Secondary Outcome
Title Concentration of Serotype-Specific IgG Antibodies
Hide Description Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study and as 0.35 ug/ml by the World Health Organization (WHO).
Time Frame 7 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed was all the available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post third dose serum available for assessment) and were in either "7vPnC+DTaP Concurrently" or "DTaP Alone" group. The "7vPnC Separately" group was not included as part of this objective.
Arm/Group Title 7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Hide Arm/Group Description:
7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP administered at 3, 4, and 5 months of age.
Overall Number of Participants Analyzed 0 66 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/ml
Serotype 4
8.99
(7.59 to 10.66)
0.01
(0.01 to 0.02)
Serotype 6B
1.19
(0.86 to 1.64)
0.06
(0.04 to 0.08)
Serotype 9V
4.9
(3.89 to 6.16)
0.06
(0.05 to 0.09)
Serotype 14
13.35
(10.31 to 17.29)
0.14
(0.09 to 0.22)
Serotype 18C
4.77
(3.79 to 6.00)
0.03
(0.02 to 0.04)
Serotype 19F
5.62
(4.45 to 7.09)
0.07
(0.05 to 0.10)
Serotype 23F
2.27
(1.68 to 3.06)
0.05
(0.03 to 0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 665.1
Confidence Interval 90%
473.3 to 851.2
Estimation Comments This analysis is for Serotype 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 22.2
Confidence Interval 90%
13.99 to 31.77
Estimation Comments This analysis is for Serotype 6B.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 73.7
Confidence Interval 90%
56.41 to 103.6
Estimation Comments This analysis is for Serotype 9V.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 99.48
Confidence Interval 90%
61.09 to 147.5
Estimation Comments This analysis is for Serotype 14.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 164
Confidence Interval 90%
114.9 to 232.9
Estimation Comments This analysis is for Serotype 18C.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 81.45
Confidence Interval 90%
57.98 to 119.1
Estimation Comments This analysis is for Serotype 19F.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 7vPnC + DTaP Concurrently, DTaP Alone
Comments The ratio of the "7vPnC + DTaP Concurrently" group to "DTaP Alone" group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 44.7
Confidence Interval 90%
29.48 to 68.71
Estimation Comments This analysis is for Serotype 23F.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Hide Arm/Group Description 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age. 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age. DTaP administered at 3, 4, and 5 months of age.
All-Cause Mortality
7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3   7   1 
Gastrointestinal disorders       
Enteritis *  1/297 (0.34%)  1/295 (0.34%)  1/201 (0.50%) 
Respiratory, thoracic and mediastinal disorders       
Bronchopneumonia *  0/297 (0.00%)  5/295 (1.69%)  1/201 (0.50%) 
Pneumonia *  1/297 (0.34%)  2/295 (0.68%)  0/201 (0.00%) 
Tachypnea *  0/297 (0.00%)  1/295 (0.34%)  0/201 (0.00%) 
Acute Bronchitis *  1/297 (0.34%)  0/295 (0.00%)  0/201 (0.00%) 
Upper respiratory infection *  1/297 (0.34%)  0/295 (0.00%)  0/201 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
7vPnC Separately 7vPnC + DTaP Concurrently DTaP Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   206   263   137 
Gastrointestinal disorders       
Diarrhea *  33/297 (11.11%)  54/295 (18.31%)  28/201 (13.93%) 
General disorders       
Pyrexia *  59/297 (19.87%)  82/295 (27.80%)  50/201 (24.88%) 
Infections and infestations       
Nasopharyngitis *  39/297 (13.13%)  54/295 (18.31%)  28/201 (13.93%) 
Upper respiratory tract infection *  20/297 (6.73%)  15/295 (5.08%)  0/201 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough *  55/297 (18.52%)  58/295 (19.66%)  31/201 (15.42%) 
*
Indicates events were collected by non-systematic assessment
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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
ClinicalTrials.gov Identifier: NCT00488826     History of Changes
Other Study ID Numbers: 0887X-101518
First Submitted: June 18, 2007
First Posted: June 20, 2007
Results First Submitted: March 31, 2009
Results First Posted: May 27, 2009
Last Update Posted: January 20, 2010