Pneumococcal VaccinesPhase 3NCT00464945

Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Vaccines, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines. Read more about this study

Who is it for?: Ages 41 to 99 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: 13-valent Pneumococcal Conjugate Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 269 participants
Where: 9 sitesPoland
Study dates: Jun 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 41 to 99 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 2 months (42 to 98 days) at time of enrollment.
Available for entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal, 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, measles, mumps, rubella, 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.

Show all 11Show fewer

Major known congenital malformation or serious chronic disorders.
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Poland9 sites

Study site
Krakow, Krakow, 30-663
Study site
Krakow, Krakow, 31-442
Study site
Lodz, Łódź Voivodeship, 91-347
Study site
Lodz, Łódź Voivodeship, 93-338
Study site
Lubartowie, Lublin Voivodeship, 21-100
Study site
Lublin, Lublin Voivodeship, 20-044
Study site
Siemianowice Śląskie, Krakow, 41-103
Study site
Torun, Bydgoszcz, 87-100
Study site
Warsaw, Warszawa, 01-184

Other trials in Poland

About this study

Official title: A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

Conditions: Pneumococcal Vaccines
Being tested: 13-valent Pneumococcal Conjugate Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13-valent Pneumococcal Conjugate VaccineBiological
1 dose at 2,3,4 and 12 months of age

Study groups in NCT00464945
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Active comparator	Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Percentages of participants achieving 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.
Measured: One month after 3-dose infant series (5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema 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.
Measured: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Measured: During the 4-day period after toddler dose
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (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.
Measured: One month after 3-dose infant series (5 months of age)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2008

First posted24 Apr 2007 (estimated)
Study startJun 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal VaccinesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464945
Sponsor's protocol ID: 6096A1-3000
Status last verified: Jul 2012
First submitted: 23 Apr 2007
Last updated: 15 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.
PubMed 21335032

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only

All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
ClinicalTrials.gov ID: NCT00464945
Acronym / sponsor ID: 6096A1-3000
Conditions: Pneumococcal Vaccines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 24 Apr 2007 (estimated)
Results: Posted 15 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Active comparator	Biological: 13-valent Pneumococcal Conjugate Vaccine

Who may qualify

Ages: 41 to 99 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged 2 months (42 to 98 days) at time of enrollment.
Available for entire study period and whose parent/legal guardian can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Key exclusion criteria (11 listed)

Previous vaccination with licensed or investigational pneumococcal, 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, measles, mumps, rubella, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent Pneumococcal Conjugate Vaccine1 dose at 2,3,4 and 12 months of age	Biological	1, 2

Primary outcome

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (5 months of age)
Percentages of participants achieving 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.
Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: During the 4-day period after each dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema 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.
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Time frame: During the 4-day period after each dose
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Time frame: During the 4-day period after toddler dose
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.
Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (5 months of age)
Antibody concentration/geometric mean concentration (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.

Results and safety

Results posted to the registry on 15 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC Manufacturing	135	131
13vPnC Pilot	134	133

Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series

Time frame: One month after 3-dose infant series (5 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC Manufacturing n = 128	13vPnC Pilot n = 131
Common Serotypes-Serotype 4	97.7 (93.3 to 99.5)	96.9 (92.4 to 99.2)
Common Serotypes-Serotype 6B	77.3 (69.1 to 84.3)	74.0 (65.7 to 81.3)
Common Serotypes-Serotype 9V	98.4 (94.5 to 99.8)	96.2 (91.3 to 98.7)
Common Serotypes-Serotype 14	92.9 (87.0 to 96.7)	94.5 (89.1 to 97.8)
Common Serotypes-Serotype 18C	96.1 (91.1 to 98.7)	93.1 (87.4 to 96.8)
Common Serotypes-Serotype 19F	98.4 (94.4 to 99.8)	97.7 (93.5 to 99.5)
Common Serotypes-Serotype 23F	82.8 (75.1 to 88.9)	81.7 (74.0 to 87.9)
Additional Serotypes-Serotype 1	93.0 (87.1 to 96.7)	90.8 (84.5 to 95.2)

13vPnC Manufacturing vs 13vPnC Pilot: Difference: 0.7 (95% CI -3.9 to 5.6)
13vPnC Manufacturing vs 13vPnC Pilot: Difference: 3.3 (95% CI -7.3 to 13.8)
13vPnC Manufacturing vs 13vPnC Pilot: Difference: 2.3 (95% CI -2.1 to 7.3)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions

Time frame: During the 4-day period after each dose. Number. Unit: percentage of participants

Measure	13vPnC Manufacturing Dose 1 n = 134	13vPnC Pilot Dose 1 n = 134	13vPnC Manufacturing Dose 2 n = 132	13vPnC Pilot Dose 2 n = 133	13vPnC Manufacturing Dose 3 n = 132	13vPnC Pilot Dose 3 n = 133	13vPnC Manufacturing Toddler Dose n = 131	13vPnC Pilot Toddler Dose n = 131
Tenderness-Any (n=133,130,128,128,124,119,115,117)	18.8	20.0	20.3	17.2	15.3	12.6	24.3	29.1
Tenderness-Sig (n=131,129,128,128,124,119,112,114)	0.8	3.9	1.6	3.1	1.6	0.0	1.8	3.5
Swelling-Any (n=132,130,129,129,126,122,113,115)	25.0	20.0	30.2	27.1	29.4	30.3	22.1	26.1
Swelling-Mild (n=132,130,129,129,126,121,113,115)	22.7	17.7	29.5	25.6	27.0	25.6	22.1	25.2
Swelling-Mod (n=132,129,128,128,124,120,113,114)	6.1	7.0	8.6	8.6	8.9	13.3	8.8	8.8
Swelling-Severe(n=131,129,128,128,124,119,112,113)	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Redness-Any (n=132,131,129,131,125,123,115,116)	28.8	24.4	37.2	33.6	40.0	34.1	37.4	42.2
Redness-Mild (n=132,131,129,131,125,123,115,115)	28.8	22.9	36.4	33.6	38.4	33.3	33.9	36.5

Population analysed: The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.

Primary outcome: Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)

Time frame: During the 4-day period after each dose. Number. Unit: percentage of participants

Measure	13vPnC Manufacturing Dose 1 n = 134	13vPnC Pilot Dose 1 n = 134	13vPnC Manufacturing Dose 2 n = 132	13vPnC Pilot Dose 2 n = 133	13vPnC Manufacturing Dose 3 n = 132	13vPnC Pilot Dose 3 n = 133
Fever ≥38°C but ≤39°C (n=132,130,129,130,124,121)	18.2	19.2	16.3	20.0	11.3	17.4
Fever >39°C but ≤40°C (n=131,129,128,128,124,119)	0.8	0.8	0.8	1.6	0.0	3.4
Fever >40°C (n=131,129,128,128,124,119)	0.0	0.0	0.0	0.0	0.0	0.0
Decreased appetite (n=133,129,129,128,125,121)	20.3	24.0	14.7	15.6	16.8	19.0
Irritability (n=134,131,130,131,127,123)	50.0	51.9	53.8	49.6	41.7	37.4
Increased sleep (n=132,129,128,129124,121)	41.7	39.5	25.0	29.5	20.2	30.6
Decreased sleep (n=132,130,129,129,124,123)	27.3	32.3	24.0	20.9	18.5	19.5
Meds to treat sx (n=132,130,128,128,124,123)	12.9	17.7	13.3	14.1	8.9	14.6

Population analysed: The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.

Primary outcome: Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)

Time frame: During the 4-day period after toddler dose. Number. Unit: percentage of participants

Measure	13vPnC Manufacturing n = 131	13vPnC Pilot n = 131
Fever ≥38°C but ≤39°C (n=114,114)	14.0	13.2
Fever >39°C but ≤40°C (n=112,113)	0.9	0.9
Fever >40°C (n=112,113)	0.0	0.0
Decreased appetite (n=115,117)	20.9	23.1
Irritability (n=119,123)	40.3	44.7
Increased sleep (n=114,119)	18.4	16.8
Decreased sleep (n=116,117)	13.8	13.7
Medication to treat symptoms (n=113,115)	17.7	17.4

Population analysed: The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Manufacturing Infant Series	4 of 134 (3%)	70 of 134 (52.2%)	Not reported
13vPnC Pilot Infant Series	2 of 134 (1.5%)	68 of 134 (50.7%)	Not reported
13vPnC Manufacturing Post-Infant Series	10 of 134 (7.5%)	3 of 134 (2.2%)	Not reported
13vPnC Pilot Post-Infant Series	11 of 134 (8.2%)	7 of 134 (5.2%)	Not reported
13vPnC Manufacturing Toddler Series	0 of 131 (0%)	48 of 131 (36.6%)	Not reported
13vPnC Pilot Toddler Series	1 of 131 (0.8%)	55 of 131 (42%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21335032Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

Related trials for Pneumococcal Vaccines

RecruitingObservational study
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Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Poland, WPWZMED@wyeth.com

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Vaccines, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series (time frame: One month after 3-dose infant series (5 months of age)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464945, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.