- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00962780
Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
13. november 2014 opdateret af: Pfizer
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine.
All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
303
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bucuresti, Rumænien, 021105
- Pfizer Investigational Site
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Bucuresti, Rumænien, 030303
- Pfizer Investigational Site
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Constanta, Rumænien, 900709
- Pfizer Investigational Site
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Bloemfontein, Sydafrika, 9301
- Pfizer Investigational Site
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Paarl, Sydafrika, 7626
- Pfizer Investigational Site
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2013
- Pfizer Investigational Site
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Pretoria, Gauteng, Sydafrika, 0083
- Pfizer Investigational Site
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Pretoria, Gauteng, Sydafrika, 0122
- Pfizer Investigational Site
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Soweto, Gauteng, Sydafrika, 1818
- Pfizer Investigational Site
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KwaZulu-Natal
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Dundee, KwaZulu-Natal, Sydafrika, 3000
- Pfizer Investigational Site
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Western Cape
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Worcester, Western Cape, Sydafrika, 6850
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
- Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before study vaccination
- Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
- No previous vaccination with a pneumococcal vaccine
- Subject or parent/legal guardian able to complete an electronic diary
Exclusion Criteria:
- Acquired immune deficiency syndrome (AIDS) at time of enrollment
- Current illicit substance and/or alcohol abuse
- History of active chronic viral hepatitis
- Previous anaphylactic reaction to a vaccine or vaccine-related component
- Serious chronic disorders including metastatic malignancy and end-stage renal disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
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13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Tidsramme: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
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1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented.
GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated.
Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay.
GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
|
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
|
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Tidsramme: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
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1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Tidsramme: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws.
CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Tidsramme: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Tidsramme: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay.
GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws.
CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
|
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Tidsramme: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
|
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented.
GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws.
CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
|
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
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Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
|
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
|
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
|
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay.
GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated.
Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws.
CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
|
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Tidsramme: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
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GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results.
Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
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1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Tidsramme: Within 14 days after 13vPnC Dose 1
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Specific local reactions were prompted for each day, and reported using an electronic diary.
Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years).
Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Report of severe swelling was confirmed as data entry error.
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Within 14 days after 13vPnC Dose 1
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Tidsramme: Within 14 days after 13vPnC Dose 2
|
Specific local reactions were prompted for each day, and reported using an electronic diary.
Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years).
Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
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Within 14 days after 13vPnC Dose 2
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Tidsramme: Within 14 days after 13vPnC Dose 3
|
Specific local reactions were prompted for each day, and reported using an electronic diary.
Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years).
Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
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Within 14 days after 13vPnC Dose 3
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Tidsramme: Within 14 days after 13vPnC Dose 1
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Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary.
Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity).
Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration).
Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
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Within 14 days after 13vPnC Dose 1
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Tidsramme: Within 14 days after 13vPnC Dose 2
|
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary.
Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity).
Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration).
Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
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Within 14 days after 13vPnC Dose 2
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Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Tidsramme: Within 14 days after 13vPnC Dose 3
|
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary.
Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity).
Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration).
Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
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Within 14 days after 13vPnC Dose 3
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2010
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. april 2013
Datoer for studieregistrering
Først indsendt
18. august 2009
Først indsendt, der opfyldte QC-kriterier
19. august 2009
Først opslået (Skøn)
20. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomsegenskaber
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Streptokokinfektioner
- Gram-positive bakterielle infektioner
- Infektioner
- Overførbare sygdomme
- Pneumokokinfektioner
- Lægemidlers fysiologiske virkninger
- Immunologiske faktorer
- Vacciner
- Heptavalent pneumokokkonjugatvaccine
Andre undersøgelses-id-numre
- 6115A1-3002
- B1851021
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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