|Study||Reason for exclusion|
|Ambrosch 1976||Data tables and figure missing|
|Aoki 1986||Randomised controlled trial, single blind. Outcomes were clinical cases and adverse effects. Follow up data were not reported by arms|
|Atmar 1995||No outcomes of interest|
|Ausseil 1999||No design (average days of sick leave in vaccinated and not vaccinated subjects during 1996 and 1997 in staff personal of an international banking institution)|
|Banzhoff 2001||No design (cohort), no safety outcomes|
|Belshe 2001||No original data|
|Benke 2004||Questionnaire survey; non comparative analysis|
|Betts 1977b||Trial with swine vaccine (Hsw1N1, A/New Jersey/76)|
|Carlson 1979||No adequate control, no outcome of interest|
|Cate 1977||Trial with swine vaccine (Hsw1N1, A/New Jersey/76)|
|Chlibek 2002||The study is not a randomised controlled trial|
|Clover 1991||Randomised controlled trial. More than 75% of the study population is out of the range of age stated in the protocol|
|Confavreux 2001||Participants are MS cases|
|Das Gupta 2002||The study does not contain effectiveness data|
|Davies 1972||Cohort with efficacy outcomes. Experimental and control group were separately selected|
|Davies 1973||The study was not randomised. Subjects volunteered for immunisation and comparison was made with a randomly selected non immunised control group|
|De Serres 2003a||No comparison, absence of adequate control group|
|De Serres 2003b||No control|
|De Serres 2004||Population at risk of further Oculo-respiratory syndrome episodes|
|Dolin 1977||Trial with swine vaccine (Hsw1N1, A/New Jersey/76)|
|Edmonson 1970||Influenza B vaccine was used as control|
|El'shina 1998||Major inconsistencies in the study text|
|Finklea 1969||Randomised controlled trial, double blind. Two bivalent inactivated influenza vaccines, with the same viral composition, differing in purification procedures, were compared. |
Outcomes were clinical cases and adverse effects.
Raw data about clinical cases were not reported by arm.
Circulating virus showed significant antigenic differences from the A2 vaccine strain
|Foy 1981||Absence of adequate control|
|Frank 1981||No usable safety data (scores)|
|Freestone 1976||Conference proceedings|
|Gerstoft 2001||The study is not a randomised controlled trial|
|Greenbaum 2002||No outcome of interest|
|Gross 1999||Outcome measures outside inclusion criteria|
|Grotto 1998||The study is not a randomised controlled trial|
|Gruber 1994||Randomised controlled trial conducted in USA on 41 cystic fibrosis (CF) patients and 89 family members, recruited through a clinic. Subjects were randomly assigned in a double-blinded fashion by family to receive either intranasal live cold-adapted influenza A vaccine or the recommended intramuscular trivalent inactivated influenza vaccine. |
The study lasted 3 years (from 1989 to 1991). Subjects were immunised each fall staying in the same assigned vaccine group. The live vaccine arm counted 20 CF and 33 family members; the trivalent vaccine arm 21 and 56 respectively.
69 of them (17 CF patients and 52 family members) dropped out. The reasons were stated in the article.
The live vaccine was the same all over the period: A/Kawasaki/9/86 (H1N1) 107,3 pfu, A/Los Angeles/2/87 107,3 pfu.
The viral strains used in the inactivated vaccines were:
- 1989-1990: A/Taiwan/1/86 (H1N1), A/Shaghai/11/87 (H3N2), B/Yagamata/16/88,15 mg/dose of each
- 1990-1991: A/Taiwan/1/86 (H1N1), A/Shaghai/16/89 (H3N2), B/Yagamata/16/88,15 mg/dose of each
- 1991-1992: A/Taiwan/1/86 (H1N1), A/Beijing/353/89 (H3N2), B/Panama/45/90, 15 mg/dose of each
Live vaccine recipient also received monovalent inactivated influenza B vaccine (identical to that contained in the trivalent vaccine) as intramuscular placebo. Allantoic fluid was the placebo for aerosol administration.
Data were extracted and loaded for family members only.
Outcomes were clinical and laboratory confirmed cases, working days lost (WDL), admissions, deaths and adverse effects.
Clinical cases were classified as "respiratory illness" or "febrile respiratory illness". Laboratory confirmed cases were defined by an influenza virus isolation from a throat swab.
Adverse effects were defined as temperature > 38°C, rhinorrhea, sore throat, cough, increasing sputum, redness, swelling, chills. Results are expressed as % of subject-days with symptoms.
Subjects were followed throughout the period. Owing to the drop outs, vaccinated were counted as subject-years: 54 in the live vaccine arm; 56 in the trivalent vaccine arm.
The influenza illness surveillance period for study subjects was defined as the interval from the date of the first influenza isolate from population under routine surveillance to 2 weeks after the last isolate for each year.
Viral strains circulating during the outbreaks were:
- 1989-1990: A/Shaghai/11/87 (H3N2)
- 1990-1991: A/Beijing/353/89 (H3N2), B/Panama/45/90-like
- 1991-1992: A/Beijing/353/89 (H3N2).
This trial was excluded since it was not placebo controlled and authors didn't specify if the strains used to develop cold adapted and inactivated vaccines were antigenically comparable or not
|Haber 2004||Analysis of temporal trends of Guillan Barrè Syndrome (GBS) 1990-2003, comparison with temporal trends of non-GBS Adverse Event reports from the Vaccine Adverse Event Reporting System (VAERS)|
|Haigh 1973||The study is not randomised: all the volunteers were immunised on a single day and the intention to allocate patients randomly was not strictly adhered to|
|Halperin 2002||Outcome measures outside inclusion criteria|
|Hobson 1970||Polivalent influenza vaccine was used as control|
|Hobson 1973||Randomised controlled trial. Clinical outcomes were side effects only|
|Hoskins 1973||Influenza B vaccine was used as control|
|Hoskins 1976a||The trial was excluded since it was not placebo/do-nothing controlled|
|Hoskins 1976b||The trial was excluded since it was not placebo/do-nothing controlled|
|Hoskins 1979||No control group|
|Howell 1967||The study is not prospective. It appears as an historical cohort.|
|Hurwitz 1983||Report of GBS surveillance 1978-79, non-comparative study|
|Jianping 1999||The study is not a randomised controlled trial|
|Keitel 2001||Efficacy outcome measures outside inclusion criteria,. The safety data are presented in a non-analyzable way|
|Kiderman 2001||Tables and text show inconsistencies that do not allow data extraction|
|Kunz 1977||No adequate control|
|Liem 1973||Liem reported the results of 9 placebo controlled clinical trials and two field studies, involving a total of about 10000 subjects, carried out in several countries to assess the efficacy of killed influenza spray vaccines. Studies were conducted during the years 1969-71. |
Allocation of the subjects to the arms of the trials was done according to a predetermined randomisation scheme. 8 of them were double-blind. The field studies were not randomised. The attack rate for influenza among the population study was very low, and in two of the trials vaccination procedure started too late, when the outbreak was ongoing. The attack rates, exclusively based on the serologically confirmed cases, are only reported by a graph and it is impossible to derive the crude data
|Mackenzie 1975||No design (allocation is arbitrary and groups with different characteristics were formed)|
|Mair 1974||Influenza B vaccine was used as control|
|Maynard 1968||Influenza B vaccine was used as control|
|Mendelman 2001||The study does not repot original results|
|Monto 2000||The study is not a randomised controlled trial|
|Morris 1975||Design is unclear (no standard random allocation. Only 25 out of 30 seem to have been immunized, but in the method description 30 were considered for exposure to natural influenza A/Scotland/840/74. One of these was prior excluded because had tonsillitis|
|Mostow 1977||Outcomes were safety only. Absence of adequate control|
|Muennig 2001||The study is not a randomised controlled trial|
|Nichol 1996||Same data as Nichol 1995|
|Nichol 1999b||The study is a review|
|Nichol 2001||The study is not a randomised controlled trial|
|Nichol 2003||The study contain data from previous studies|
|Nichol 2004||Re-analysis of Nichol 1999 (already included)|
|Pyhala 2001||The study is not a randomised controlled trial|
|Rimmelzwaan 2000||Outcome measures outside inclusion criteria|
|Rocchi 1979c||Very poor reporting, unclear definition, no description of methods|
|Ruben 1972||Absence of adequate control.|
|Ruben 1973||The study was excluded since both arms contained the same vaccine strains.|
|Safranek 1991||Re-assessment of Schoenberger 1979.|
|Sarateanu 1980||Absence of adequate control|
|Schonberger 1981||Review of the evidence of the aetiology of GBS, no original data presented|
|Schwartz 1996||Report about Nichol 1995|
|Skowronski 2002||Non-comparative (survey)|
|Skowronski 2003||Population at risk of further ORS episodes|
|Smith 1977a||The article reports a little part of the Hoskins trial. It compared illness occurring among a group of vaccinated boys against non vaccinated controls that had no part in the trial|
|Smith 1977b||Trial with swine vaccine (Hsw1N1, A/New Jersey/76)|
|Spencer 1975||Authors didn't report crude data on the clinical outcomes|
|Spencer 1979||Reporting doesn't allow one to understand the methods used to allocate subjects and to conceal allocation. Clinical outcome data are not reported|
|Taylor 1969||No outcomes of interest, rhinovirus vaccine as control|
|Treanor 2001||Outcome measures outside inclusion criteria|
|Treanor 2002||Outcome measures outside inclusion criteria|
|Tyrrell 1970||None of the 3 studies reported in this paper are includible for the following reasons: |
1. No design, no comparison, no outcomes.
2. Probable controlled clinical trial, but subjects age probably out of range (schools).
3. No design, even if an unvaccinated control group for school 3 and ICI is present
|Warshauer 1976||The study was not randomised. Data reporting was not complete|
|Wilde 1999||Pneumococcal vaccine was used as control|
|Williams 1973||No placebo/do-nothing control|
|Wood 1999||The study is not a randomised controlled trial|
|Wood 2000||The study is not a randomised controlled trial|