Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
6. juli 2012 oppdatert av: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
500
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bydgoszcz, Polen, 85-168
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Debica, Polen, 39-200
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Krakow, Polen, 31-202
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Krakow, Polen, 30-663
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Krakow, Polen, 31-422
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Lodz, Polen, 91-347
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Lubartow, Polen, 21-100
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Lublin, Polen, 20-044
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Oborniki Slaskie, Polen, 55-120
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Poznan, Polen, 60-535
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Poznan, Polen, 61-709
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Siemianowice Slaskie, Polen, 41-103
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Torun, Polen, 87-100
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Trzebnica, Polen, 55-100
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 måned til 3 måneder (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Aged 2 months (42 through 98 days) at the time of enrollment.
- Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
- In good health as determined by medical history, physical examination, and judgment of the investigator.
- Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.
Exclusion criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae.
- Major known congenital malformation or serious chronic disorder.
- Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
- Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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Aktiv komparator: 2
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Tidsramme: One month after 3-dose infant series (at 5 months of age)
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Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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One month after 3-dose infant series (at 5 months of age)
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Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Tidsramme: One month after 3-dose infant series (at 5 months of age)
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GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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One month after 3-dose infant series (at 5 months of age)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Tidsramme: one month after the toddler dose (at 13 months of age)
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Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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one month after the toddler dose (at 13 months of age)
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Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Tidsramme: one month after the toddler dose (at 13 months of age)
|
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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one month after the toddler dose (at 13 months of age)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent of Participants Reporting Pre-Specified Local Reactions
Tidsramme: Within 4-days after each dose
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Local reactions were collected using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement).
Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm).
Participants may be represented in more than 1 category.
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Within 4-days after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events
Tidsramme: Within 4-days after each dose
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Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 4-days after each dose
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Trial Manager, For Poland, WPWZMED@wyeth.com
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2006
Primær fullføring (Faktiske)
1. juni 2008
Studiet fullført (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først innsendt
17. august 2006
Først innsendt som oppfylte QC-kriteriene
18. august 2006
Først lagt ut (Anslag)
21. august 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6096A1-009
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