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Trial Outcomes & Findings for Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics (NCT NCT00836641)

NCT ID: NCT00836641

Last Updated: 2013-09-02

Results Overview

we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (\>0.35 µg/ml).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

12 months

Results posted on

2013-09-02

Participant Flow

11/2005-09/07: 70 outpatients (2-5-yo)with \>3 asthma episodes during 12 months. Exclusion: pneumococcal immunization,severe/unstable asthma, systemic steroids, preterm birth (\<37 weeks of gestation), low birthweight (\<2500 g), major congenital abnormalities, and known intolerance towards ingredients of the pneumococcal vaccines.

Participant milestones

Participant milestones
Measure
Group A: Sequential Pneumococcal Immunzation (2 mo)
one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
Group B: Sequential Pneumococcal Immunization (10 mo)
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
Overall Study
STARTED
36
34
Overall Study
COMPLETED
36
34
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A Pneumococcal Immunization (2 mo)
n=36 Participants
one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
Group B Pneumococcal Immunization (10 mo)
n=34 Participants
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
Total
n=70 Participants
Total of all reporting groups
Age, Categorical
<=18 years
36 Participants
n=5 Participants
34 Participants
n=7 Participants
70 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
3 years
STANDARD_DEVIATION 0.5 • n=5 Participants
3 years
STANDARD_DEVIATION 0.7 • n=7 Participants
3 years
STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
16 Participants
n=7 Participants
31 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
18 Participants
n=7 Participants
39 Participants
n=5 Participants
Region of Enrollment
Germany
36 participants
n=5 Participants
34 participants
n=7 Participants
70 participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: we performed a power calculation in advance. To demonstrate a difference wit p\<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm.

we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (\>0.35 µg/ml).

Outcome measures

Outcome measures
Measure
Group A Pneumococcal Immunization (2 mo)
n=36 Participants
one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
Group B Pneumococcal Immunization (10 mo)
n=34 Participants
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
Immunogenicity of Pneumococcal Vaccination
0.05 [µg/ml]
Interval 0.01 to 5.0
0.05 [µg/ml]
Interval 0.01 to 5.0

SECONDARY outcome

Timeframe: 12 months

we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.

Outcome measures

Outcome measures
Measure
Group A Pneumococcal Immunization (2 mo)
n=36 Participants
one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
Group B Pneumococcal Immunization (10 mo)
n=34 Participants
one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
Number of Vaccinees With Adverse Events
0 participants
0 participants

Adverse Events

Overall Study Population

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Markus Rose

Goethe University Childrens Hospital

Phone: 0049-696301

Results disclosure agreements

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