Trial Outcomes & Findings for Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants (NCT NCT00488826)

NCT ID: NCT00488826

Last Updated: 2010-01-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 800 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2010-01-20

Participant Flow

Subjects were recruited in China from September 2006 to May 2007.

Subjects were enrolled into study according to inclusion/exclusion criteria without a screening period.

Participant milestones

Measure	7vPnC Separately 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 + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Overall Study STARTED	300	296	204
Overall Study COMPLETED	244	244	178
Overall Study NOT COMPLETED	56	52	26

Reasons for withdrawal

Measure	7vPnC Separately 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 + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Overall Study Withdrawal by Subject	40	35	19
Overall Study Protocol Violation	0	0	2
Overall Study Adverse Event	9	15	4
Overall Study Lost to Follow-up	5	1	0
Overall Study Protocol Deviations	2	1	1

Baseline Characteristics

Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

Baseline characteristics by cohort

Measure	7vPnC Separately n=300 Participants 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 + DTaP Concurrently n=296 Participants 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone n=204 Participants DTaP administered at 3, 4, and 5 months of age.	Total n=800 Participants Total of all reporting groups
Age Continuous	3.5 months STANDARD_DEVIATION 1.0 • n=5 Participants	3.5 months STANDARD_DEVIATION 1.0 • n=7 Participants	3.5 months STANDARD_DEVIATION 1.7 • n=5 Participants	3.5 months STANDARD_DEVIATION 1.23 • n=4 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	133 Participants n=7 Participants	81 Participants n=5 Participants	356 Participants n=4 Participants
Sex: Female, Male Male	158 Participants n=5 Participants	163 Participants n=7 Participants	123 Participants n=5 Participants	444 Participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months

Population: 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.

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).

Outcome measures

Measure	7vPnC Separately n=64 Participants 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 + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone n=47 Participants DTaP administered at 3, 4, and 5 months of age.
Concentration of Serotype-Specific IgG Antibodies Serotype 4	15.26 ug/ml Interval 12.51 to 18.61	—	0.01 ug/ml Interval 0.01 to 0.02
Concentration of Serotype-Specific IgG Antibodies Serotype 6B	3.1 ug/ml Interval 2.15 to 4.46	—	0.06 ug/ml Interval 0.04 to 0.08
Concentration of Serotype-Specific IgG Antibodies Serotype 9V	6.82 ug/ml Interval 5.65 to 8.23	—	0.06 ug/ml Interval 0.05 to 0.09
Concentration of Serotype-Specific IgG Antibodies Serotype 14	17.75 ug/ml Interval 13.53 to 23.28	—	0.14 ug/ml Interval 0.09 to 0.22
Concentration of Serotype-Specific IgG Antibodies Serotype 18C	6.24 ug/ml Interval 5.07 to 7.69	—	0.03 ug/ml Interval 0.02 to 0.04
Concentration of Serotype-Specific IgG Antibodies Serotype 19F	11.77 ug/ml Interval 8.91 to 15.54	—	0.07 ug/ml Interval 0.05 to 0.1
Concentration of Serotype-Specific IgG Antibodies Serotype 23F	4.7 ug/ml Interval 3.22 to 6.86	—	0.05 ug/ml Interval 0.03 to 0.08

SECONDARY outcome

Timeframe: 7 months

Population: 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.

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).

Outcome measures

Measure	7vPnC Separately 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 + DTaP Concurrently n=66 Participants 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone n=47 Participants DTaP administered at 3, 4, and 5 months of age.
Concentration of Serotype-Specific IgG Antibodies Serotype 6B	—	1.19 ug/ml Interval 0.86 to 1.64	0.06 ug/ml Interval 0.04 to 0.08
Concentration of Serotype-Specific IgG Antibodies Serotype 9V	—	4.9 ug/ml Interval 3.89 to 6.16	0.06 ug/ml Interval 0.05 to 0.09
Concentration of Serotype-Specific IgG Antibodies Serotype 14	—	13.35 ug/ml Interval 10.31 to 17.29	0.14 ug/ml Interval 0.09 to 0.22
Concentration of Serotype-Specific IgG Antibodies Serotype 18C	—	4.77 ug/ml Interval 3.79 to 6.0	0.03 ug/ml Interval 0.02 to 0.04
Concentration of Serotype-Specific IgG Antibodies Serotype 19F	—	5.62 ug/ml Interval 4.45 to 7.09	0.07 ug/ml Interval 0.05 to 0.1
Concentration of Serotype-Specific IgG Antibodies Serotype 23F	—	2.27 ug/ml Interval 1.68 to 3.06	0.05 ug/ml Interval 0.03 to 0.08
Concentration of Serotype-Specific IgG Antibodies Serotype 4	—	8.99 ug/ml Interval 7.59 to 10.66	0.01 ug/ml Interval 0.01 to 0.02

Adverse Events

7vPnC Separately

Serious events: 3 serious events

Other events: 206 other events

Deaths: 0 deaths

7vPnC + DTaP Concurrently

Serious events: 7 serious events

Other events: 263 other events

Deaths: 0 deaths

DTaP Alone

Serious events: 1 serious events

Other events: 137 other events

Deaths: 0 deaths

Serious adverse events

Measure	7vPnC Separately 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 + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Respiratory, thoracic and mediastinal disorders Bronchopneumonia	0.00% 0/297	1.7% 5/295	0.50% 1/201
Respiratory, thoracic and mediastinal disorders Pneumonia	0.34% 1/297	0.68% 2/295	0.00% 0/201
Gastrointestinal disorders Enteritis	0.34% 1/297	0.34% 1/295	0.50% 1/201
Respiratory, thoracic and mediastinal disorders Tachypnea	0.00% 0/297	0.34% 1/295	0.00% 0/201
Respiratory, thoracic and mediastinal disorders Acute Bronchitis	0.34% 1/297	0.00% 0/295	0.00% 0/201
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.34% 1/297	0.00% 0/295	0.00% 0/201

Other adverse events

Measure	7vPnC Separately 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 + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.	DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Gastrointestinal disorders Diarrhea	11.1% 33/297	18.3% 54/295	13.9% 28/201
General disorders Pyrexia	19.9% 59/297	27.8% 82/295	24.9% 50/201
Infections and infestations Nasopharyngitis	13.1% 39/297	18.3% 54/295	13.9% 28/201
Infections and infestations Upper respiratory tract infection	6.7% 20/297	5.1% 15/295	0.00% 0/201
Respiratory, thoracic and mediastinal disorders Cough	18.5% 55/297	19.7% 58/295	15.4% 31/201

Additional Information

U. S. Contact Center

Wyeth

Email: clintrialresults@wyeth.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER